The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for (calas(tm)) W/add'l Reagent Calas(tm) Pronase.
| Device ID | K894845 |
| 510k Number | K894845 |
| Device Name: | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE |
| Classification | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Wayne Gade |
| Correspondent | Wayne Gade MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | GMD |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-11 |
| Decision Date | 1989-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101090 | K894845 | 000 |
| 00840733101083 | K894845 | 000 |