Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- MiscellaneousMiscellaneous
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUProduct Code
- NGMTest, Phencyclidine (Pcp), Over The CounterUProduct Code
- OTWResearch Use Only/Clinical ToxicologyNProduct Code
- OXR5-Fluorouracil AssayNProduct Code
- PDBInvestigational Use Only - Clinical ToxicologyNProduct Code
- PGEGastric Emptying Breath Test3Product Code
- PKMChemiluminescent Immunoassay SystemNProduct Code
- PRFDocetaxel / Paclitaxel AssayNProduct Code
- PSSMinoxidil Sulfotransferase Or Isoenzymes Test SystemNProduct Code
- LAOEnzyme Immunoassay, MethotrexateUProduct Code
- LCLRadioimmunoassay, PhencyclidineUProduct Code
- LCMEnzyme Immunoassay, PhencyclidineUProduct Code
- LTDParaquat Assay3Product Code
- MGXTest System, For Drugs Of Abuse3Product Code
- MIGStrip, Test IsoniazidUProduct Code
- MSKImmunoassay For Blood TacrolimusNProduct Code
- PZNPlacental Growth Factor TestNProduct Code
- QBBPlacental Alpha Microglobulin-1 Immunoassay3Product Code
- QWHPrognostic Test For Development Or Progression Of Preeclampsia2Product Code
- QXTInfliximab Test System2Product Code
- QYDAdalimumab Assay2Product Code
- QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit3Product Code
- Submissions with No Product CodeMiscellaneous
- K875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMCleared 510(K)
- K872737PERKIN-ELMER LC235 DIODE ARRAY DETECTORCleared 510(K)
- K842549ACA ACETAMINOPHEN CALIBRATORCleared 510(K)
- K842673EMIT LOW & MEDIUM CALIBRATORS ACleared 510(K)
- K830694DUPONT PREP TYPE CS EXTRACTION CARTRIDECleared 510(K)
- K810271DIRECT CURRENT BONE GROWTH STIM. AN. PADCleared 510(K)
- K802622EMIT-STM URINE CONTROLSCleared 510(K)
- K801566CYBREX PHENOBARBITALCleared 510(K)
- K801567CYBREX THEOPHYLLINECleared 510(K)
- K801565CYBREX PHENYTOINCleared 510(K)
Show All 18 Submissions
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
DIRECT CURRENT BONE GROWTH STIM. AN. PAD
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K810271
- 510(k) Type
- Traditional
- Applicant
- ANDOVER MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/19/1981
- Days to Decision
- 17 days