The following data is part of a premarket notification filed by Alfa Wassermann, Inc. with the FDA for S-test Lactate Dehydrogenase (ld), Model Rc 0017.
Device ID | K091544 |
510k Number | K091544 |
Device Name: | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 |
Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
Applicant | ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
Contact | Hyman Katz |
Correspondent | Hyman Katz ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
Product Code | CFJ |
CFR Regulation Number | 862.1440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-27 |
Decision Date | 2009-09-09 |
Summary: | summary |