ANTISMOOTH MUSCLE ANTIBODY TEST SYS
FDA 510(k) clearance K810983 · decided 1981-05-01
Clearance details
- K-number
- K810983
- Device name
- ANTISMOOTH MUSCLE ANTIBODY TEST SYS
- Applicant
- Immuno-Products Industries
- Decision
- Substantially Equivalent
- Date received
- 1981-04-13
- Decision date
- 1981-05-01
- Days to decision
- 18 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
+ Add to Predicate Builder ◉ Watch Immuno-Products Industries
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 |
|---|---|---|
| AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (K800820) | Calbiochem-Behring Corp. | 1980-04-24 |
| IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT (K800228) | Clinical Sciences, Inc. | 1980-02-21 |
| 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.