The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Verify Reference Plasma And Mda Verify Ref. Plasma.
| Device ID | K930849 |
| 510k Number | K930849 |
| Device Name: | VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-18 |
| Decision Date | 1993-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420708 | K930849 | 000 |