STANDARDIZE TGCL & TGCH
FDA 510(k) clearance K781376 · decided 1978-09-14
Clearance details
- K-number
- K781376
- Device name
- STANDARDIZE TGCL & TGCH
- Applicant
- American Monitor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-09
- Decision date
- 1978-09-14
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JTX
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANAEROBIC ACCU-CULSHURE(TM) (K901645) | Medical Laboratory Automation Systems, Inc. | 1990-07-16 |
| ACUSON V328 AND C5432 TRANSDUCERS (K897151) | Acuson Corp. | 1990-07-03 |
| ACCU-CULSHURE TM (K882637) | Accu-Med Corp. | 1988-07-06 |
| BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (K791724) | Marion Laboratories, Inc. | 1979-10-17 |
| ANASWAB (K780159) | Scott Laboratories, Inc. | 1978-02-13 |
| PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (K761241) | Gibco Laboratories Life Technologies, Inc. | 1976-12-30 |
| SPECIMEN COLLECTOR, ANAEROBIC (K760063) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 |
Recalls involving this device
No recalls on record reference this clearance.