Transport Systems, Anaerobic
Transport Systems, Anaerobic are specimen collection and transport systems designed to preserve anaerobic microorganisms by maintaining an oxygen-free environment from sample collection through laboratory receipt, ensuring viability of obligate anaerobes for culture and identification. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JTX, regulated under 21 CFR 866.2900, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JTX
- Device Class
- FDA class 1
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | Jul 16, 1990 | Substantially Equivalent | Medical Laboratory Automation Systems, Inc. |
| K897151 | ACUSON V328 AND C5432 TRANSDUCERS | Jul 03, 1990 | Substantially Equivalent | Acuson Corp. |
| K882637 | ACCU-CULSHURE TM | Jul 06, 1988 | Substantially Equivalent | Accu-Med Corp. |
| K791724 | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) | Oct 17, 1979 | Substantially Equivalent | Marion Laboratories, Inc. |
| K781376 | STANDARDIZE TGCL & TGCH | Sep 14, 1978 | Substantially Equivalent | American Monitor Corp. |
| K780159 | ANASWAB | Feb 13, 1978 | Substantially Equivalent | Scott Laboratories, Inc. |
| K761241 | PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE | Dec 30, 1976 | Substantially Equivalent | Gibco Laboratories Life Technologies, Inc. |
| K760063 | SPECIMEN COLLECTOR, ANAEROBIC | Aug 03, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.