The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Monolisa Anti-hav Igm Eia.
| Device ID | K092353 |
| 510k Number | K092353 |
| Device Name: | MONOLISA ANTI-HAV IGM EIA |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Contact | Linda Staswick |
| Correspondent | Linda Staswick BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847865012379 | K092353 | 000 |