JTS · Stains, Microbiologic
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | JTS |
|---|---|
| Device Name | Stains, Microbiologic |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960095 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | Mar 19, 1996 | SESE |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | Mar 19, 1996 | SESE |
| K920976 | BACTIDROP INDIA INK | Remel Co. | Jun 9, 1992 | SESE |
| K920975 | BACTIDROP CALCOFLUOR WHITE | Remel Co. | Jun 9, 1992 | SESE |
| K920970 | BACTIDROP KOH (10%) | Remel Co. | Jun 9, 1992 | SESE |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | Intl. Remote Imaging Systems | Jun 13, 1989 | SESE |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | Alpha-Tec Systems, Inc. | Mar 23, 1989 | SESE |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Alpha-Tec Systems, Inc. | Feb 24, 1989 | SESE |
| K884069 | SNAP N' STAIN IODINE STAIN | Scientific Device Laboratory, Inc. | Oct 25, 1988 | SESE |
| K883052 | METHENO-STAIN KIT | Scientific Device Laboratory, Inc. | Aug 30, 1988 | SESE |
| K883061 | ATS PARA-SET CARBOL-XYLENE SOLUTION | Alpha-Tech Systems, Inc. | Aug 17, 1988 | SESE |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | Alpha-Tec Systems, Inc. | Aug 17, 1988 | SESE |
| K880989 | ATS CRYPTOSPORIDIUM STAIN SET | Alpha-Tec Systems, Inc. | May 13, 1988 | SESE |
| K881598 | SDL TRICHROME STAIN | Scientific Device Laboratory, Inc. | May 4, 1988 | SESE |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | Wescor, Inc. | Apr 18, 1988 | SESE |
| K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | Alpha-Tec Systems, Inc. | Mar 30, 1988 | SESE |
| K880718 | CALCOFLUOR WHITE STAIN KIT | Remel Co. | Mar 25, 1988 | SESE |
| K874662 | MYCO-FLUOR REAGENT A & B | Scott Laboratories, Inc. | Nov 25, 1987 | SESE |
| K873413 | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR | Lakewood Biochemical Co., Inc. | Oct 6, 1987 | SESE |
| K872189 | METHANOL, ABSOLUTE | Remel Co. | Jul 29, 1987 | SESE |
Top Applicants
- Remel Co. — 12 clearances
- Alpha-Tec Systems, Inc. — 5 clearances
- Accra Laboratories, Inc. — 4 clearances
- Scientific Device Laboratory, Inc. — 3 clearances
- Marion Laboratories, Inc. — 2 clearances
