The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Absorbance (abs) Test Pak.
Device ID | K854784 |
510k Number | K854784 |
Device Name: | ABSORBANCE (ABS) TEST PAK |
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 | 1985-11-29 |
Decision Date | 1985-12-19 |