APPRAISE-CARDIO SAMPLE COLLECTION KIT
FDA 510(k) clearance K993787 · decided 2000-04-14
Clearance details
- K-number
- K993787
- Device name
- APPRAISE-CARDIO SAMPLE COLLECTION KIT
- Applicant
- Osborn Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-09
- Decision date
- 2000-04-14
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Olathe, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit contains recall (Z-0535-2012) | Heritage Labs International LLC | 2012-01-11 |
| AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Produc recall (Z-0542-2012) | Heritage Labs International LLC | 2012-01-11 |
| Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains recall (Z-0579-2012) | Heritage Labs International LLC | 2012-01-11 |