The following data is part of a premarket notification filed by International Enzymes, Inc. with the FDA for Hscrp Control Level 1, Hscrp Control Level 2, And Hscrp Control Level 3.
| Device ID | K011169 |
| 510k Number | K011169 |
| Device Name: | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | INTERNATIONAL ENZYMES, INC. 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero INTERNATIONAL ENZYMES, INC. 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010240 | K011169 | 000 |
| 00817238010226 | K011169 | 000 |
| 00817238010219 | K011169 | 000 |