The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Frt4 Immunoassay.
Device ID | K961510 |
510k Number | K961510 |
Device Name: | ACS FRT4 IMMUNOASSAY |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
Contact | Thomas F Flynn |
Correspondent | Thomas F Flynn CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-19 |
Decision Date | 1996-06-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414294087 | K961510 | 000 |
00630414555331 | K961510 | 000 |
00630414555324 | K961510 | 000 |
00630414555317 | K961510 | 000 |
00630414598284 | K961510 | 000 |
00630414598277 | K961510 | 000 |