The following data is part of a premarket notification filed by Biomed Diagnostics, Inc. with the FDA for Intray Gc.
| Device ID | K993033 |
| 510k Number | K993033 |
| Device Name: | INTRAY GC |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | BIOMED DIAGNOSTICS, INC. 1430 KOLL CIRCLE, SUITE 101 San Jose, CA 95112 |
| Contact | Robert D Hall |
| Correspondent | Robert D Hall BIOMED DIAGNOSTICS, INC. 1430 KOLL CIRCLE, SUITE 101 San Jose, CA 95112 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-09 |
| Decision Date | 1999-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B08810804 | K993033 | 000 |