The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Quik-dot C Reactive Protein.
Device ID | K892119 |
510k Number | K892119 |
Device Name: | QUIK-DOT C REACTIVE PROTEIN |
Classification | C-reactive Protein, Antigen, Antiserum, And Control |
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 | DCK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-31 |
Decision Date | 1989-04-14 |