The following data is part of a premarket notification filed by Iris Diagnostics with the FDA for Irispec,ca/cb/cc.
| Device ID | K072640 |
| 510k Number | K072640 |
| Device Name: | IRISPEC,CA/CB/CC |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | IRIS DIAGNOSTICS 9172 ETON AVE. Chatsworth, CA 91311 |
| Contact | Gerald Haddock |
| Correspondent | Gerald Haddock IRIS DIAGNOSTICS 9172 ETON AVE. Chatsworth, CA 91311 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-18 |
| Decision Date | 2007-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10837461002680 | K072640 | 000 |
| 10837461002611 | K072640 | 000 |