The following data is part of a premarket notification filed by Hach Company with the FDA for Sterichek Blood Leak Reagent Strips.
| Device ID | K042322 |
| 510k Number | K042322 |
| Device Name: | STERICHEK BLOOD LEAK REAGENT STRIPS |
| Classification | Detector, Leak, Blood |
| Applicant | HACH COMPANY 23575 COUNTY ROAD 106 Elkhart, IN 46514 |
| Contact | David A Morris, Ph.d. |
| Correspondent | David A Morris, Ph.d. HACH COMPANY 23575 COUNTY ROAD 106 Elkhart, IN 46514 |
| Product Code | FJD |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-26 |
| Decision Date | 2004-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851575007129 | K042322 | 000 |
| 00851575007105 | K042322 | 000 |