The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Immunology Control.
| Device ID | K960824 |
| 510k Number | K960824 |
| Device Name: | IMMUNOLOGY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-29 |
| Decision Date | 1996-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011601 | K960824 | 000 |
| 00884883011595 | K960824 | 000 |
| 00884883011588 | K960824 | 000 |
| 00884883003569 | K960824 | 000 |
| 00884883003552 | K960824 | 000 |
| 00884883003545 | K960824 | 000 |
| 00884883003538 | K960824 | 000 |