510(k) K210511
- Device
- InTray GC
- Applicant
- Biomed Diagnostics Incorporated
- 510(k) number
- K210511
- Product code
- JTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-20
- Date received
- 2021-02-23
- Regulation
- 866.2410
- Classification name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John F Antiabong
- Address
- 1388 Antelope Rd. White City OR US 97503 97503
FDA Registration Numbers#
- 1119779
- 2022807
- 1111096
- 1924669
- 3009547954
- 2951280
Source Documents#
Other 510(k) Records For Product Code JTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993033 | INTRAY GC | Biomed Diagnostics, Inc. | 1999-12-16 |
| K954986 | GC BASE W/ 1% GCHI | Remel, L.P. | 1996-02-16 |
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Bioclinical Systems, Inc. | 1995-06-30 |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Bioclinical Systems, Inc. | 1994-02-09 |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Bioclinical Systems, Inc. | 1994-02-03 |
| K934331 | THAYER MARTIN, MODIFIED PILL POCKET | Hardy Diagnostics | 1993-12-21 |
| K934330 | TRANSGROW | Hardy Diagnostics | 1993-12-17 |
| K931864 | MARTIN LEWIS WITH LINOCMYCIN | Hardy Diagnostics | 1993-12-15 |
| K881552 | PROTEOSE NO. 3 AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881527 | CASMAN MEDIUM BASE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 |
| K864253 | THAYER MARTIN AGAR | Mds Laboratories, Inc. | 1987-03-31 |
| K864252 | THAYER-MARTIN JEMBEC | Mds Laboratories, Inc. | 1987-03-31 |
| K864803 | GC-LECT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-03 |
| K864078 | MODIFIED N.Y.C. FERMENTATION MEDIUM BASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 |
Legacy Summary#
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FDA Review#
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