The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hy-tec Automated Eia System.
| Device ID | K941278 |
| 510k Number | K941278 |
| Device Name: | HY-TEC AUTOMATED EIA SYSTEM |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Thomas J Foley |
| Correspondent | Thomas J Foley HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1995-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879022322 | K941278 | 000 |
| 00816879022858 | K941278 | 000 |
| 00816879022087 | K941278 | 000 |
| 00816879022094 | K941278 | 000 |
| 00816879022131 | K941278 | 000 |
| 00816879022148 | K941278 | 000 |
| 00816879022186 | K941278 | 000 |
| 00816879022223 | K941278 | 000 |
| 00816879022247 | K941278 | 000 |
| 00816879022261 | K941278 | 000 |
| 00816879022292 | K941278 | 000 |
| 00816879022315 | K941278 | 000 |
| 00816879022841 | K941278 | 000 |