ATROXIN
FDA 510(k) clearance K780355 · decided 1978-04-18
Clearance details
- K-number
- K780355
- Device name
- ATROXIN
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-03
- Decision date
- 1978-04-18
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- JCO
- Device class
- 2
- Regulation number
- 864.8100
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| VENOM TIEM REAGENT (K955115) | Medical Diagnostic Technologies, Inc. | 1996-04-03 |
| BATROXOBIN REAGENT (K932787) | Behring Diagnostics, Inc. | 1993-11-29 |
| FDP COLLECTION TUBES (K896033) | Medical Diagnostic Technologies, Inc. | 1989-10-27 |
| DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (K852519) | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 |
| REPTILASE -PC (K843207) | Bio/Data Corp. | 1984-10-23 |
| REPTILASE-R HA35 (K840210) | Wellcome Diagnostics | 1984-04-23 |
Recalls involving this device
No recalls on record reference this clearance.