The following data is part of a premarket notification filed by Chemicon Intl., Inc. with the FDA for Light Diagnostics Pneumocystis Carinii Dfa, Model 31965.
| Device ID | K992252 |
| 510k Number | K992252 |
| Device Name: | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 |
| Classification | Pneumocystis Carinii |
| Applicant | CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Cindy Penny |
| Correspondent | Cindy Penny CHEMICON INTL., INC. 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | LYF |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252401121 | K992252 | 000 |
| 04053252730351 | K992252 | 000 |