TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
FDA 510(k) clearance K760156 · decided 1976-07-20
Clearance details
- K-number
- K760156
- Device name
- TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-02
- Decision date
- 1976-07-20
- 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 Zeus Scientific
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 |
|---|---|---|
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |