The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Acid Phosphatase Reagent Set.
| Device ID | K902495 |
| 510k Number | K902495 |
| Device Name: | ACID PHOSPHATASE REAGENT SET |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001198 | K902495 | 000 |