Standardize TGCL & TGCH
FDA 510(k) K781376 · American Monitor Corp.
510(k) numberK781376
Submission
- Device name
- Standardize TGCL & TGCH
- Applicant
- American Monitor Corp.
Mchenry, IL, US - Received
- August 9, 1978
- Decision date
- September 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTX – Transport Systems, Anaerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901645 | Anaerobic Accu-Culshure(Tm)JTX · Traditional | Medical Laboratory Automation Systems, Inc. | 07/16/1990SE |
| K897151 | Acuson V328 and C5432 TransducersJTX · Traditional | Acuson Corp. | 07/03/1990SE |
| K882637 | Accu-Culshure TMJTX · Traditional | Accu-Med Corp. | 07/06/1988SE |
| K791724 | Bio-Bag Environmental Chamber (a & B)JTX · Traditional | Marion Laboratories, Inc. | 10/17/1979SE |
| K780159 | AnaswabJTX · Traditional | Scott Laboratories, Inc. | 02/13/1978SE |
| K761241 | Pre-Duced Surgi-Swab & Transporter TubeJTX · Traditional | Gibco Laboratories Life Technologies, Inc. | 12/30/1976SE |
| K760063 | Specimen Collector, AnaerobicJTX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1976SE |
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| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
Questions and answers
When was Standardize TGCL & TGCH cleared by the FDA?
Standardize TGCL & TGCH (K781376) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 36 days after the submission was received.
What is the product code of K781376?
The FDA product code is JTX – Transport Systems, Anaerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.