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 |