The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Alkaline Phosphatase Liquid Reagent-kinetic, Models A504-150 And A504-500h.
| Device ID | K000067 |
| 510k Number | K000067 |
| Device Name: | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Dindo Carrillo |
| Correspondent | Dindo Carrillo TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002362 | K000067 | 000 |
| 10673486001044 | K000067 | 000 |
| 00850053916014 | K000067 | 000 |