JTX · Transport Systems, Anaerobic
Microbiology · 21 CFR 866.2900 · Class 1
Overview
| Product Code | JTX |
|---|---|
| Device Name | Transport Systems, Anaerobic |
| Regulation | 21 CFR 866.2900 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Classification Rationale
Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | Medical Laboratory Automation Systems, Inc. | Jul 16, 1990 | SESE |
| K897151 | ACUSON V328 AND C5432 TRANSDUCERS | Acuson Corp. | Jul 3, 1990 | SESE |
| K882637 | ACCU-CULSHURE TM | Accu-Med Corp. | Jul 6, 1988 | SESE |
| K791724 | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) | Marion Laboratories, Inc. | Oct 17, 1979 | SESE |
| K781376 | STANDARDIZE TGCL & TGCH | American Monitor Corp. | Sep 14, 1978 | SESE |
| K780159 | ANASWAB | Scott Laboratories, Inc. | Feb 13, 1978 | SESE |
| K761241 | PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE | Gibco Laboratories Life Technologies, Inc. | Dec 30, 1976 | SESE |
| K760063 | SPECIMEN COLLECTOR, ANAEROBIC | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 3, 1976 | SESE |
Top Applicants
- Accu-Med Corp. — 1 clearance
- Acuson Corp. — 1 clearance
- American Monitor Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Gibco Laboratories Life Technologies, Inc. — 1 clearance
