The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Qualicheck 4 Metabolite(s3630,s3640,s3650,s3660).
| Device ID | K961354 |
| 510k Number | K961354 |
| Device Name: | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-14 |
| Summary: | summary |