The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Pneumocystis Carinii Immunofluorescence Test Kit.
Device ID | K890768 |
510k Number | K890768 |
Device Name: | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT |
Classification | Pneumocystis Carinii |
Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Contact | S Krieger,phd |
Correspondent | S Krieger,phd GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Product Code | LYF |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-15 |
Decision Date | 1989-03-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847865001519 | K890768 | 000 |
00847865001502 | K890768 | 000 |