The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Coat-a-count Total Ige Irma, Catalog #ikie1, Ikie2.
| Device ID | K901859 |
| 510k Number | K901859 |
| Device Name: | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 |
| Classification | Radioimmunoassay, Immunoglobulins (d, E) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | B Asarch,phd |
| Correspondent | B Asarch,phd DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JHR |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414953458 | K901859 | 000 |