The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Serum Volatiles Control Level 1 & 2.
| Device ID | K955691 |
| 510k Number | K955691 |
| Device Name: | SERUM VOLATILES CONTROL LEVEL 1 & 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-14 |
| Decision Date | 1996-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238011599 | K955691 | 000 |
| 00817238011582 | K955691 | 000 |