The following data is part of a premarket notification filed by Ampcor Diagnostics, Inc. with the FDA for Adi Syphilis Rpr Liquid Controls.
| Device ID | K980638 |
| 510k Number | K980638 |
| Device Name: | ADI SYPHILIS RPR LIQUID CONTROLS |
| Classification | Antisera, Control For Nontreponemal Tests |
| Applicant | AMPCOR DIAGNOSTICS, INC. 603 HERON DR., BLDG. 3 Bridgeport, NJ 08104 |
| Contact | Raymond Miller |
| Correspondent | Raymond Miller AMPCOR DIAGNOSTICS, INC. 603 HERON DR., BLDG. 3 Bridgeport, NJ 08104 |
| Product Code | GMP |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902769095 | K980638 | 000 |