BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
FDA 510(k) clearance K032764 · decided 2003-11-03
Clearance details
- K-number
- K032764
- Device name
- BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-05
- Decision date
- 2003-11-03
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Synnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); recall (Z-0846-2012) | Lin-Zhi International Inc | 2012-01-24 |