J&S HDL CHOLESTEROL PRECIPITATING REAGENT
FDA 510(k) clearance K900218 · decided 1990-06-18
Clearance details
- K-number
- K900218
- Device name
- J&S HDL CHOLESTEROL PRECIPITATING REAGENT
- Applicant
- J.S. Medical Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-17
- Decision date
- 1990-06-18
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- LBL
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.