The following data is part of a premarket notification filed by Hach Company with the FDA for Opaciden Opa Reagent Strips.
| Device ID | K070419 |
| 510k Number | K070419 |
| Device Name: | OPACIDEN OPA REAGENT STRIPS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | HACH COMPANY 23575 COUNTY ROAD 106 Elkhart, IN 46514 |
| Contact | David A Morris |
| Correspondent | David A Morris HACH COMPANY 23575 COUNTY ROAD 106 Elkhart, IN 46514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-13 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10615375008574 | K070419 | 000 |