The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Absorbance Test Solution.
| Device ID | K853533 |
| 510k Number | K853533 |
| Device Name: | ABSORBANCE TEST SOLUTION |
| Classification | Calibrator, Secondary |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Raymond L Miller |
| Correspondent | Raymond L Miller DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1985-09-16 |