The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Certain Hct Level A & Level B/cvm Hct Levels 1,2,3, & 4.
| Device ID | K961807 |
| 510k Number | K961807 |
| Device Name: | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 |
| Classification | Control, Hematocrit |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | GLK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1996-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414121796 | K961807 | 000 |
| 00630414121789 | K961807 | 000 |