Kit, Quality Control For Culture Media
Kit, Quality Control for Culture Media is a laboratory kit containing reference microorganisms or reagents used to verify the performance and sterility of culture media lots before they are placed into routine clinical laboratory use. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JTR, regulated under 21 CFR 866.2480, and falls within the Microbiology medical specialty.
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Basic Information
- Product Code
- JTR
- Device Class
- FDA class 1
- Regulation Number
- 866.2480
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871121 | PROTECT T.M. | Apr 14, 1987 | Substantially Equivalent | Pro-Lab, Inc. |
| K862914 | FEKAL CHECK PARASITOLOGY CONTROL SLIDE | Sep 16, 1986 | Substantially Equivalent | Trend Scientific, Inc. |
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | Apr 04, 1986 | Substantially Equivalent | Micro-Bio-Logics |
| K855198 | INDI KWIK (TM) CO/TWO KIT | Jan 14, 1986 | Substantially Equivalent | Micro-Bio-Logics |
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | Jul 27, 1984 | Substantially Equivalent | Biological & Environmental Control Laboratories |
| K842129 | LYFO-DISK MICROORGANISMS | Jul 03, 1984 | Substantially Equivalent | Micro-Bio-Logics |
| K831653 | LYOPHILIZED MICROORGANISMS | Jul 28, 1983 | Substantially Equivalent | Austin Biological Laboratories |
| K830133 | Q-CHECK CULTI-LOOPS | Feb 09, 1983 | Substantially Equivalent | Lab Ability, Inc. |
| K822954 | MICROTECH BACTERIAL CONTROLS | Nov 16, 1982 | Substantially Equivalent | Universal Micro Reference Laboratory |
| K821660 | BIO-CHECK GRAM STAIN CONTROL | Jun 25, 1982 | Substantially Equivalent | American Scientific Products |
| K820064 | SUSCEPTROL | Jan 28, 1982 | Substantially Equivalent | American Type Culture Collection |
| K812698 | GC DISK | Oct 06, 1981 | Substantially Equivalent | Remel Co. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.