The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer.
Device ID | K812100 |
510k Number | K812100 |
Device Name: | SERALYZER |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-24 |
Decision Date | 1981-08-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SERALYZER 73344913 1235570 Dead/Cancelled |
Miles Laboratories, Inc. 1982-01-08 |
SERALYZER 73012562 1004725 Dead/Expired |
MILES LABORATORIES, INC. 1974-02-04 |