The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Modified Crp Latex Test.
| Device ID | K880016 |
| 510k Number | K880016 |
| Device Name: | MODIFIED CRP LATEX TEST |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-02-25 |