Atlas FDA

JTS

40 FDA 510(k) clearances · Product code

34 daysmedian time to decision
68 days90th percentile
40clearances measured

FDA profile

Official device name
Stains, Microbiologic
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Medical specialty
Hematology
Flags
GMP exempt
Adverse events (MAUDE)
1998: 1 · 2020: 106 · 2024: 21 · 2025: 102 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BACTIDROP CALCOFLUOR WHITE (K960095)Remel Co.1996-03-19
CALCOFLUOR WHITE STAIN KIT (K960090)Remel Co.1996-03-19
BACTIDROP INDIA INK (K920976)Remel Co.1992-06-09
BACTIDROP CALCOFLUOR WHITE (K920975)Remel Co.1992-06-09
BACTIDROP KOH (10%) (K920970)Remel Co.1992-06-09
IRISTAIN FORMULA 2, PARTS 1 AND 2 (K893530)Intl. Remote Imaging Systems1989-06-13
ATS DOBELL & O'CONNOR'S IODINE (K890861)Alpha-Tec Systems, Inc.1989-03-23
ATS LUGOL'S IODINE SOLUTION (K890020)Alpha-Tec Systems, Inc.1989-02-24
SNAP N' STAIN IODINE STAIN (K884069)Scientific Device Laboratory, Inc.1988-10-25
METHENO-STAIN KIT (K883052)Scientific Device Laboratory, Inc.1988-08-30
ATS PARA-SET CARBOL-XYLENE SOLUTION (K883061)Alpha-Tech Systems, Inc.1988-08-17
ATS PARA-SET IODINE ALCOHOL SOLUTION (K883049)Alpha-Tec Systems, Inc.1988-08-17
ATS CRYPTOSPORIDIUM STAIN SET (K880989)Alpha-Tec Systems, Inc.1988-05-13
SDL TRICHROME STAIN (K881598)Scientific Device Laboratory, Inc.1988-05-04
WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY (K881512)Wescor, Inc.1988-04-18
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) (K881042)Alpha-Tec Systems, Inc.1988-03-30
CALCOFLUOR WHITE STAIN KIT (K880718)Remel Co.1988-03-25
MYCO-FLUOR REAGENT A & B (K874662)Scott Laboratories, Inc.1987-11-25
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR (K873413)Lakewood Biochemical Co., Inc.1987-10-06
TB KINYOUN CARBOLFUCHSIN (K872187)Remel Co.1987-07-29
TB METHYLENE BLUE (K872184)Remel Co.1987-07-29
METHANOL, ABSOLUTE (K872189)Remel Co.1987-07-29
LIGHT GREEN (K872185)Remel Co.1987-07-29
SULFURIC ACID 10% (K872186)Remel Co.1987-07-29
SPOTTEST FLAGELLA STAIN (K871606)Difco Laboratories, Inc.1987-05-15
TOMTEC GRAM STAINER CRYSTAL VIOLET (K871532)Remel Co.1987-04-29
PRICE'S ACID-FAST STAIN (K870988)Devetec, Inc.1987-03-30
GRAM STAIN KIT (K853896)Sigma Diagnostics, Inc.1985-10-22
KINYOUN ACID FAST STAIN KIT (K851493)Accra Laboratories, Inc.1985-04-29
TWO-STEP ACID FAST BACTERIA STAIN (K851494)Accra Laboratories, Inc.1985-04-29
GRAM STAIN SET W/STABILIZED IODINE (K843429)Accra Laboratories, Inc.1984-09-14
GRAM STAIN (K843050)Reagent Laboratory, Inc.1984-09-11
TRICHROME STAIN (K831060)American Micro Scan1983-06-08
FAST VIOLET B (K821038)Dms Laboratories1982-05-27
GRAM STAIN REAGENTS AND KIT (K813369)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-22
AFB STAIN SET (K812668)Carr-Scarborough Microbiologicals, Inc.1981-09-29
ACCRA-LAB GRAM STAIN SET 55760 (K811780)Accra Laboratories, Inc.1981-07-27
ACID FAST KIT (K781643)Bioscientific1978-10-03
DROPPERS, SOLUTION, IODINE (K781061)Marion Laboratories, Inc.1978-08-14
MIF PROCEDURE KIT (K780346)Marion Laboratories, Inc.1978-03-22

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Every clearance here is in the API, with alerts when new ones post.