The following data is part of a premarket notification filed by Reprocessing Products Corp. with the FDA for E-z Chek Blood Leak Test Strips.
| Device ID | K123805 |
| 510k Number | K123805 |
| Device Name: | E-Z CHEK BLOOD LEAK TEST STRIPS |
| Classification | Detector, Leak, Blood |
| Applicant | REPROCESSING PRODUCTS CORP. P.O. BOX 35849 Tucson, AZ 85740 |
| Contact | Ted Williams |
| Correspondent | Ted Williams REPROCESSING PRODUCTS CORP. P.O. BOX 35849 Tucson, AZ 85740 |
| Product Code | FJD |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-11 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858293006397 | K123805 | 000 |
| 00858293006175 | K123805 | 000 |