The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Rpr Test For Syphilis In Serum Or Plasma.
Device ID | K880477 |
510k Number | K880477 |
Device Name: | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA |
Classification | Antigens, Nontreponemal, All |
Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Contact | Raymond Gould |
Correspondent | Raymond Gould AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Product Code | GMQ |
CFR Regulation Number | 866.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-04 |
Decision Date | 1988-03-30 |