HEMAFLUOR REAGENT KIT
FDA 510(k) clearance K860309 · decided 1986-07-14
Clearance details
- K-number
- K860309
- Device name
- HEMAFLUOR REAGENT KIT
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-01-28
- Decision date
- 1986-07-14
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- KHO
- Device class
- 1
- Regulation number
- 862.2560
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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| AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K923021) | Tosoh Corp. | 1992-07-21 |
| MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (K920888) | Dynatech Laboratories, Inc. | 1992-03-19 |
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Recalls involving this device
No recalls on record reference this clearance.