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 |