The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Bayer Healthcare Rapidqc Plus.
| Device ID | K870036 |
| 510k Number | K870036 |
| Device Name: | BAYER HEALTHCARE RAPIDQC PLUS |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414118444 | K870036 | 000 |
| 00630414118413 | K870036 | 000 |
| 00630414118383 | K870036 | 000 |