ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
FDA 510(k) clearance K791387 · decided 1979-08-16
Clearance details
- K-number
- K791387
- Device name
- ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
- Applicant
- Immuno-Mycologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-11
- Decision date
- 1979-08-16
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JWT
- Device class
- 1
- Regulation number
- 866.3040
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Immuno-Mycologics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (K812740) | Nolan Biological Laboratories, Inc. | 1981-10-20 |
| ASPERGILLUS SP, COMPLEMENT FIXATION (K792700) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (K790672) | Diagnostica, Inc. | 1979-05-31 |
| ASPERGILLUS MYCELIAL ANTIGEN (K760830) | I M, Inc. | 1976-11-01 |
Recalls involving this device
No recalls on record reference this clearance.