Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- JTSStains, Microbiologic1Product Code
- K960090CALCOFLUOR WHITE STAIN KIT1Cleared 510(K)
- K960095BACTIDROP CALCOFLUOR WHITE1Cleared 510(K)
- K920975BACTIDROP CALCOFLUOR WHITE1Cleared 510(K)
- K920976BACTIDROP INDIA INK1Cleared 510(K)
- K920970BACTIDROP KOH (10%)1Cleared 510(K)
- K893530IRISTAIN FORMULA 2, PARTS 1 AND 21Cleared 510(K)
- K890861ATS DOBELL & O'CONNOR'S IODINE1Cleared 510(K)
- K890020ATS LUGOL'S IODINE SOLUTION1Cleared 510(K)
- K884069SNAP N' STAIN IODINE STAIN1Cleared 510(K)
- K883052METHENO-STAIN KIT1Cleared 510(K)
- K883061ATS PARA-SET CARBOL-XYLENE SOLUTION1Cleared 510(K)
- K883049ATS PARA-SET IODINE ALCOHOL SOLUTION1Cleared 510(K)
- K880989ATS CRYPTOSPORIDIUM STAIN SET1Cleared 510(K)
- K881598SDL TRICHROME STAIN1Cleared 510(K)
- K881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY1Cleared 510(K)
- K881042ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)1Cleared 510(K)
- K880718CALCOFLUOR WHITE STAIN KIT1Cleared 510(K)
- K874662MYCO-FLUOR REAGENT A & B1Cleared 510(K)
- K873413GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR1Cleared 510(K)
- K872186SULFURIC ACID 10%1Cleared 510(K)
- K872185LIGHT GREEN1Cleared 510(K)
- K872184TB METHYLENE BLUE1Cleared 510(K)
- K872189METHANOL, ABSOLUTE1Cleared 510(K)
- K872187TB KINYOUN CARBOLFUCHSIN1Cleared 510(K)
- K871606SPOTTEST FLAGELLA STAIN1Cleared 510(K)
- K871532TOMTEC GRAM STAINER CRYSTAL VIOLET1Cleared 510(K)
- K870988PRICE'S ACID-FAST STAIN1Cleared 510(K)
- K853896GRAM STAIN KIT1Cleared 510(K)
- K851493KINYOUN ACID FAST STAIN KIT1Cleared 510(K)
- K851494TWO-STEP ACID FAST BACTERIA STAIN1Cleared 510(K)
- K843429GRAM STAIN SET W/STABILIZED IODINE1Cleared 510(K)
- K843050GRAM STAIN1Cleared 510(K)
- K831060TRICHROME STAIN1Cleared 510(K)
- K821038FAST VIOLET B1Cleared 510(K)
- K813369GRAM STAIN REAGENTS AND KIT1Cleared 510(K)
- K812668AFB STAIN SET1Cleared 510(K)
- K811780ACCRA-LAB GRAM STAIN SET 557601Cleared 510(K)
- K781643ACID FAST KIT1Cleared 510(K)
- K781061DROPPERS, SOLUTION, IODINE1Cleared 510(K)
- K780346MIF PROCEDURE KIT1Cleared 510(K)
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GRAM STAIN REAGENTS AND KIT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K813369
- 510(k) Type
- Traditional
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/1981
- Days to Decision
- 22 days