IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
FDA 510(k) clearance K800228 · decided 1980-02-21
Clearance details
- K-number
- K800228
- Device name
- IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
- Applicant
- Clinical Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-05
- Decision date
- 1980-02-21
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DBE
- Device class
- 2
- Regulation number
- 866.5120
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| ANTISMOOTH MUSCLE ANTIBODY TEST SYS (K810983) | Immuno-Products Industries | 1981-05-01 |
| AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (K800820) | Calbiochem-Behring Corp. | 1980-04-24 |
| MEDICA II-F-ASMA TEST KIT (K790430) | Medica Corp. | 1979-04-23 |
| ANTI-MITOCHONDRIAL (K771155) | Meloy Laboratories, Inc. | 1977-08-04 |
| TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (K760156) | Zeus Scientific, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.