IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
FDA 510(k) clearance K802128 · decided 1980-09-26
Clearance details
- K-number
- K802128
- Device name
- IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
- Applicant
- Nolan Biological Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-04
- Decision date
- 1980-09-26
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JWW
- Device class
- 2
- Regulation number
- 866.3060
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION (K792683) | Meridian Diagnostics, Inc. | 1980-01-23 |
| BLASTOMYCES DERMATITIDIS, ANTIGEN (K792680) | Meridian Diagnostics, Inc. | 1980-01-17 |
Recalls involving this device
No recalls on record reference this clearance.