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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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Gastroenterology and Urology
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General Hospital
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Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
DII
Columns, Glc
1
Product Code
DJA
Column Supports, Glc
1
Product Code
DJO
Indicator, Cellulose Fluorescent, Tlc
1
Product Code
DJS
U.V. Light, Tlc
1
Product Code
DJY
Ion-Exchange Chromatography
1
Product Code
DKG
Plate, Cellulose, Tlc
1
Product Code
DKK
Tanks, Developing, Tlc
1
Product Code
DKO
Adsorbents, Ion-Exchange
1
Product Code
DKS
Plate, Silica Gel, Tlc
1
Product Code
DKY
Indicator, Alumina Fluorescent, Tlc
1
Product Code
DLC
Atomizer, Tlc
1
Product Code
DLG
Coating, Liquid, Glc
1
Product Code
DLO
Indicator, Silica Gel Fluorescent, Tlc
1
Product Code
DLY
Plate, Alumina, Tlc
1
Product Code
DMG
Papers, Ion
1
Product Code
DMS
Gases, Glc
1
Product Code
DMZ
Liquid Chromatography, Adsorbent
1
Product Code
DNH
Resins, Ion-Exchange, Liquid Chromatography
1
Product Code
DOP
Mass Spectrometer, Clinical Use
1
Product Code
DPA
Apparatus, General Use, Thin Layer Chromatography
1
Product Code
DPM
Columns, Liquid Chromatography
1
Product Code
JSQ
Chromatography For Bacterial Identification
1
Product Code
JXQ
Monitor, U.V., Glc
1
Product Code
JXR
Atomic Absorption Spectrophotometer, General Use
1
Product Code
KEA
Resins, Ion-Exchange
1
Product Code
KIE
Apparatus, High Pressure Liquid Chromatography
1
Product Code
KZQ
Chromatography(Gas), Clinical Use
1
Product Code
KZR
Chromatography (Liquid, Gel), Clinical Use
1
Product Code
KZS
Chromatography (Thin Layer), Clinical Use
1
Product Code
LDM
Instrumentation, High Pressure Liquid Chromatography
1
Product Code
K
96
0392
CDM
1
Cleared 510(K)
K
96
1557
ALLIANCE 2690 SEPARATIONS MODULE
1
Cleared 510(K)
K
94
2451
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
1
Cleared 510(K)
K
92
2388
WATERS(TM) LC MODULE I FOR CLINICAL USE
1
Cleared 510(K)
K
92
0136
WATERS 717 AUTOSAMPLER
1
Cleared 510(K)
K
90
3647
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
1
Cleared 510(K)
K
88
4886
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
1
Cleared 510(K)
K
87
2582
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
1
Cleared 510(K)
K
87
0949
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
1
Cleared 510(K)
K
86
2178
ISOPURE LC SYSTEM
1
Cleared 510(K)
Show All 19 Submissions
LEQ
Detectors, Electrochemical, Liquid Chromatography
1
Product Code
PFF
High Throughput Dna Sequence Analyzer
2
Product Code
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Manual Hematology Devices
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
TX
/
subpart-c—clinical-laboratory-instruments
/
LDM
/
K922388
View Source
WATERS(TM) LC MODULE I FOR CLINICAL USE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922388
510(k) Type
Traditional
Applicant
MILLIPORE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/1992
Days to Decision
114 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart C—Clinical Laboratory Instruments
DII
Columns, Glc
DJA
Column Supports, Glc
DJO
Indicator, Cellulose Fluorescent, Tlc
DJS
U.V. Light, Tlc
DJY
Ion-Exchange Chromatography
DKG
Plate, Cellulose, Tlc
DKK
Tanks, Developing, Tlc
DKO
Adsorbents, Ion-Exchange
DKS
Plate, Silica Gel, Tlc
DKY
Indicator, Alumina Fluorescent, Tlc
DLC
Atomizer, Tlc
DLG
Coating, Liquid, Glc
DLO
Indicator, Silica Gel Fluorescent, Tlc
DLY
Plate, Alumina, Tlc
DMG
Papers, Ion
DMS
Gases, Glc
DMZ
Liquid Chromatography, Adsorbent
DNH
Resins, Ion-Exchange, Liquid Chromatography
DOP
Mass Spectrometer, Clinical Use
DPA
Apparatus, General Use, Thin Layer Chromatography
DPM
Columns, Liquid Chromatography
JSQ
Chromatography For Bacterial Identification
JXQ
Monitor, U.V., Glc
JXR
Atomic Absorption Spectrophotometer, General Use
KEA
Resins, Ion-Exchange
KIE
Apparatus, High Pressure Liquid Chromatography
KZQ
Chromatography(Gas), Clinical Use
KZR
Chromatography (Liquid, Gel), Clinical Use
KZS
Chromatography (Thin Layer), Clinical Use
LDM
Instrumentation, High Pressure Liquid Chromatography
K
96
0392
CDM
K
96
1557
ALLIANCE 2690 SEPARATIONS MODULE
K
94
2451
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K
92
2388
WATERS(TM) LC MODULE I FOR CLINICAL USE
K
92
0136
WATERS 717 AUTOSAMPLER
K
90
3647
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K
88
4886
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K
87
2582
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K
87
0949
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K
86
2178
ISOPURE LC SYSTEM
Show All 19 Submissions
LEQ
Detectors, Electrochemical, Liquid Chromatography
PFF
High Throughput Dna Sequence Analyzer
Subpart D—Clinical Toxicology Test Systems
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart H—Hematology Kits and Packages
Medical Genetics
Unknown
TX
/
subpart-c—clinical-laboratory-instruments
/
LDM
/
K922388
View Source
WATERS(TM) LC MODULE I FOR CLINICAL USE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922388
510(k) Type
Traditional
Applicant
MILLIPORE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/1992
Days to Decision
114 days
Submission Type
Statement