HPL RIA KIT
FDA 510(k) clearance K863188 · decided 1986-09-25
Clearance details
- K-number
- K863188
- Device name
- HPL RIA KIT
- Applicant
- Biotecx Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-19
- Decision date
- 1986-09-25
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JMX
- Device class
- 1
- Regulation number
- 862.1515
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Friendswood, TX, 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 |
|---|---|---|
| NINHYDRIN REAGENT KIT (K780847) | Beckman Instruments, Inc. | 1978-06-13 |
Recalls involving this device
No recalls on record reference this clearance.