NEGATIVE CONTROL SERUM FOR CF RO ID
FDA 510(k) clearance K791385 · decided 1979-08-16
Clearance details
- K-number
- K791385
- Device name
- NEGATIVE CONTROL SERUM FOR CF RO ID
- 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
- GSN
- Device class
- 2
- Regulation number
- 866.3085
- 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 |
|---|---|---|
| SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM (K952145) | Sa Scientific, Inc. | 1995-07-18 |
| IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL (K885113) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
Recalls involving this device
No recalls on record reference this clearance.