The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Carbon Dioxide, Creatinine And Lactate Dehydrogenase Flex Reagent Cartridge.
| Device ID | K061238 |
| 510k Number | K061238 |
| Device Name: | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Product Code | KHS |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CGX |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015625 | K061238 | 000 |