The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Referee Blood Gas Analyzer Controls.
| Device ID | K830181 |
| 510k Number | K830181 |
| Device Name: | REFEREE BLOOD GAS ANALYZER CONTROLS |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
| Contact | Ronald Smernoff |
| Correspondent | Ronald Smernoff ANALYTICAL PRODUCTS, INC. 511 TAYLOR WAY Belmont , CA 94002 - |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-28 |