JTR · Kit, Quality Control For Culture Media
Microbiology · 21 CFR 866.2480 · Class 1
Overview
| Product Code | JTR |
|---|---|
| Device Name | Kit, Quality Control For Culture Media |
| Regulation | 21 CFR 866.2480 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871121 | PROTECT T.M. | Pro-Lab, Inc. | Apr 14, 1987 | SESE |
| K862914 | FEKAL CHECK PARASITOLOGY CONTROL SLIDE | Trend Scientific, Inc. | Sep 16, 1986 | SESE |
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | Micro-Bio-Logics | Apr 4, 1986 | SESE |
| K855198 | INDI KWIK (TM) CO/TWO KIT | Micro-Bio-Logics | Jan 14, 1986 | SESE |
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | Biological & Environmental Control Laboratories | Jul 27, 1984 | SESE |
| K842129 | LYFO-DISK MICROORGANISMS | Micro-Bio-Logics | Jul 3, 1984 | SESE |
| K831653 | LYOPHILIZED MICROORGANISMS | Austin Biological Laboratories | Jul 28, 1983 | SESE |
| K830133 | Q-CHECK CULTI-LOOPS | Lab Ability, Inc. | Feb 9, 1983 | SESE |
| K822954 | MICROTECH BACTERIAL CONTROLS | Universal Micro Reference Laboratory | Nov 16, 1982 | SESE |
| K821660 | BIO-CHECK GRAM STAIN CONTROL | American Scientific Products | Jun 25, 1982 | SESE |
| K820064 | SUSCEPTROL | American Type Culture Collection | Jan 28, 1982 | SESE |
| K812698 | GC DISK | Remel Co. | Oct 6, 1981 | SESE |
Top Applicants
- Micro-Bio-Logics — 3 clearances
- American Scientific Products — 1 clearance
- American Type Culture Collection — 1 clearance
- Austin Biological Laboratories — 1 clearance
- Biological & Environmental Control Laboratories — 1 clearance
