The following data is part of a premarket notification filed by Farallon Medial Inc with the FDA for Immedia Prothrombin Time System.
| Device ID | K050243 |
| 510k Number | K050243 |
| Device Name: | IMMEDIA PROTHROMBIN TIME SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | FARALLON MEDIAL INC 3521 INVESTEMENT BLVD SUITE 1 Hayward, CA 94545 |
| Contact | James Mckinley |
| Correspondent | James Mckinley FARALLON MEDIAL INC 3521 INVESTEMENT BLVD SUITE 1 Hayward, CA 94545 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-02 |
| Decision Date | 2005-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861900000312 | K050243 | 000 |
| 00861900000305 | K050243 | 000 |