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 |