AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
FDA 510(k) clearance K862300 · decided 1986-07-29
Clearance details
- K-number
- K862300
- Device name
- AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
- Applicant
- Amresco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-17
- Decision date
- 1986-07-29
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JGM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Solon, OH, 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 |
|---|---|---|
| LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER (K895718) | Data Medical Associates, Inc. | 1989-10-19 |
| MSI-NAK-50 TEST KIT (K831300) | Medical Specialties, Inc. | 1983-07-18 |
| SODIUM & POTASSIUM TEST KIT (K810253) | Mallinckrodt Critical Care | 1981-02-10 |
| TRIGLYCERIDE KIT (K771068) | Environmental Chemical Specialties | 1977-07-12 |
Recalls involving this device
No recalls on record reference this clearance.