Product code JTS
- Device name
- Stains, Microbiologic
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960095 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | 1996-03-19 |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | 1996-03-19 |
| K920976 | BACTIDROP INDIA INK | Remel Co. | 1992-06-09 |
| K920975 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | 1992-06-09 |
| K920970 | BACTIDROP KOH (10%) | Remel Co. | 1992-06-09 |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | Intl. Remote Imaging Systems | 1989-06-13 |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | Alpha-Tec Systems, Inc. | 1989-03-23 |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Alpha-Tec Systems, Inc. | 1989-02-24 |
| K884069 | SNAP N' STAIN IODINE STAIN | Scientific Device Laboratory, Inc. | 1988-10-25 |
| K883052 | METHENO-STAIN KIT | Scientific Device Laboratory, Inc. | 1988-08-30 |
| K883061 | ATS PARA-SET CARBOL-XYLENE SOLUTION | Alpha-Tech Systems, Inc. | 1988-08-17 |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | Alpha-Tec Systems, Inc. | 1988-08-17 |
| K880989 | ATS CRYPTOSPORIDIUM STAIN SET | Alpha-Tec Systems, Inc. | 1988-05-13 |
| K881598 | SDL TRICHROME STAIN | Scientific Device Laboratory, Inc. | 1988-05-04 |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | Wescor, Inc. | 1988-04-18 |
| K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | Alpha-Tec Systems, Inc. | 1988-03-30 |
| K880718 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | 1988-03-25 |
| K874662 | MYCO-FLUOR REAGENT A & B | Scott Laboratories, Inc. | 1987-11-25 |
| K873413 | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR | Lakewood Biochemical Co., Inc. | 1987-10-06 |
| K872189 | METHANOL, ABSOLUTE | Remel Co. | 1987-07-29 |
| K872187 | TB KINYOUN CARBOLFUCHSIN | Remel Co. | 1987-07-29 |
| K872186 | SULFURIC ACID 10% | Remel Co. | 1987-07-29 |
| K872185 | LIGHT GREEN | Remel Co. | 1987-07-29 |
| K872184 | TB METHYLENE BLUE | Remel Co. | 1987-07-29 |
| K871606 | SPOTTEST FLAGELLA STAIN | Difco Laboratories, Inc. | 1987-05-15 |
| K871532 | TOMTEC GRAM STAINER CRYSTAL VIOLET | Remel Co. | 1987-04-29 |
| K870988 | PRICE'S ACID-FAST STAIN | Devetec, Inc. | 1987-03-30 |
| K853896 | GRAM STAIN KIT | Sigma Diagnostics, Inc. | 1985-10-22 |
| K851493 | KINYOUN ACID FAST STAIN KIT | Accra Laboratories, Inc. | 1985-04-29 |
| K851494 | TWO-STEP ACID FAST BACTERIA STAIN | Accra Laboratories, Inc. | 1985-04-29 |
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|---|---|---|---|
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| 00673693169011 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693236461 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00810047422068 | N/A | Scientific Device Laboratory, Inc. | 2024-07-11 |
| 00810047420705 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421092 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421030 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420811 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420804 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420798 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420781 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420750 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420743 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420736 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420729 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420712 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420620 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420613 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420453 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420392 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420385 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420378 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420255 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420248 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420163 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420156 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420149 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00816085022000 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085023472 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 10885380158971 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-07-13 |