The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Inorganic Phosphorus(colorimetric) Reagent Set.
Device ID | K915708 |
510k Number | K915708 |
Device Name: | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
Contact | Chen |
Correspondent | Chen TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-29 |
Decision Date | 1992-01-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10673486001945 | K915708 | 000 |