The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for In Vitro Diagnostic Regeant Set,cholinesterase.
| Device ID | K914171 |
| 510k Number | K914171 |
| Device Name: | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE |
| Classification | Colorimetry, Cholinesterase |
| Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1991-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001488 | K914171 | 000 |