FDA Product Code
FDA Product Code JTS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960095 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | 1996-03-19 | Traditional | PDF ↗ |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | 1996-03-19 | Traditional | PDF ↗ |
| K920970 | BACTIDROP KOH (10%) | Remel Co. | 1992-06-09 | Traditional | PDF ↗ |
| K920976 | BACTIDROP INDIA INK | Remel Co. | 1992-06-09 | Traditional | PDF ↗ |
| K920975 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | 1992-06-09 | Traditional | PDF ↗ |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | Intl. Remote Imaging Systems | 1989-06-13 | Traditional | PDF ↗ |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | Alpha-Tec Systems, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Alpha-Tec Systems, Inc. | 1989-02-24 | Traditional | PDF ↗ |
| K884069 | SNAP N' STAIN IODINE STAIN | Scientific Device Laboratory, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K883052 | METHENO-STAIN KIT | Scientific Device Laboratory, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K883061 | ATS PARA-SET CARBOL-XYLENE SOLUTION | Alpha-Tech Systems, Inc. | 1988-08-17 | Traditional | PDF ↗ |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | Alpha-Tec Systems, Inc. | 1988-08-17 | Traditional | PDF ↗ |
| K880989 | ATS CRYPTOSPORIDIUM STAIN SET | Alpha-Tec Systems, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K881598 | SDL TRICHROME STAIN | Scientific Device Laboratory, Inc. | 1988-05-04 | Traditional | PDF ↗ |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | Wescor, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | Alpha-Tec Systems, Inc. | 1988-03-30 | Traditional | PDF ↗ |
| K880718 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | 1988-03-25 | Traditional | PDF ↗ |
| K874662 | MYCO-FLUOR REAGENT A & B | Scott Laboratories, Inc. | 1987-11-25 | Traditional | PDF ↗ |
| K873413 | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR | Lakewood Biochemical Co., Inc. | 1987-10-06 | Traditional | PDF ↗ |
| K872186 | SULFURIC ACID 10% | Remel Co. | 1987-07-29 | Traditional | PDF ↗ |
| K872187 | TB KINYOUN CARBOLFUCHSIN | Remel Co. | 1987-07-29 | Traditional | PDF ↗ |
| K872189 | METHANOL, ABSOLUTE | Remel Co. | 1987-07-29 | Traditional | PDF ↗ |
| K872184 | TB METHYLENE BLUE | Remel Co. | 1987-07-29 | Traditional | PDF ↗ |
| K872185 | LIGHT GREEN | Remel Co. | 1987-07-29 | Traditional | PDF ↗ |
| K871606 | SPOTTEST FLAGELLA STAIN | Difco Laboratories, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K871532 | TOMTEC GRAM STAINER CRYSTAL VIOLET | Remel Co. | 1987-04-29 | Traditional | PDF ↗ |
| K870988 | PRICE'S ACID-FAST STAIN | Devetec, Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K853896 | GRAM STAIN KIT | Sigma Diagnostics, Inc. | 1985-10-22 | Traditional | PDF ↗ |
| K851493 | KINYOUN ACID FAST STAIN KIT | Accra Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K851494 | TWO-STEP ACID FAST BACTERIA STAIN | Accra Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K843429 | GRAM STAIN SET W/STABILIZED IODINE | Accra Laboratories, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K843050 | GRAM STAIN | Reagent Laboratory, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K831060 | TRICHROME STAIN | American Micro Scan | 1983-06-08 | Traditional | PDF ↗ |
| K821038 | FAST VIOLET B | Dms Laboratories | 1982-05-27 | Traditional | PDF ↗ |
| K813369 | GRAM STAIN REAGENTS AND KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-22 | Traditional | PDF ↗ |
| K812668 | AFB STAIN SET | Carr-Scarborough Microbiologicals, Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K811780 | ACCRA-LAB GRAM STAIN SET 55760 | Accra Laboratories, Inc. | 1981-07-27 | Traditional | PDF ↗ |
| K781643 | ACID FAST KIT | Bioscientific | 1978-10-03 | Traditional | PDF ↗ |
| K781061 | DROPPERS, SOLUTION, IODINE | Marion Laboratories, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K780346 | MIF PROCEDURE KIT | Marion Laboratories, Inc. | 1978-03-22 | Traditional | PDF ↗ |
Product code JTS · Class I · Hematology. Data: openFDA.