JTS — Stains, Microbiologic Class I
FDA product code JTS covers "Stains, Microbiologic", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JTS
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K960095 | remel | BACTIDROP CALCOFLUOR WHITE | March 19, 1996 |
| K960090 | remel | CALCOFLUOR WHITE STAIN KIT | March 19, 1996 |
| K920970 | remel | BACTIDROP KOH (10%) | June 9, 1992 |
| K920976 | remel | BACTIDROP INDIA INK | June 9, 1992 |
| K920975 | remel | BACTIDROP CALCOFLUOR WHITE | June 9, 1992 |
| K893530 | intl. remote imaging systems | IRISTAIN FORMULA 2, PARTS 1 AND 2 | June 13, 1989 |
| K890861 | alpha-tec systems | ATS DOBELL & O'CONNOR'S IODINE | March 23, 1989 |
| K890020 | alpha-tec systems | ATS LUGOL'S IODINE SOLUTION | February 24, 1989 |
| K884069 | scientific device laboratory | SNAP N' STAIN IODINE STAIN | October 25, 1988 |
| K883052 | scientific device laboratory | METHENO-STAIN KIT | August 30, 1988 |
| K883061 | alpha-tech systems | ATS PARA-SET CARBOL-XYLENE SOLUTION | August 17, 1988 |
| K883049 | alpha-tec systems | ATS PARA-SET IODINE ALCOHOL SOLUTION | August 17, 1988 |
| K880989 | alpha-tec systems | ATS CRYPTOSPORIDIUM STAIN SET | May 13, 1988 |
| K881598 | scientific device laboratory | SDL TRICHROME STAIN | May 4, 1988 |
| K881512 | wescor | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | April 18, 1988 |
| K881042 | alpha-tec systems | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | March 30, 1988 |
| K880718 | remel | CALCOFLUOR WHITE STAIN KIT | March 25, 1988 |
| K874662 | scott laboratories | MYCO-FLUOR REAGENT A & B | November 25, 1987 |
| K873413 | lakewood biochemical co | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR | October 6, 1987 |
| K872184 | remel | TB METHYLENE BLUE | July 29, 1987 |