510(k) K863188
- Device
- HPL RIA KIT
- Applicant
- BIOTECX LABORATORIES, INC.
- 510(k) number
- K863188
- Product code
- JMX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-25
- Date received
- 1986-08-19
- Regulation
- 862.1515
- Classification name
- Ninhydrin, Nitrogen (amino-nitrogen)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MEHRA, PH.D.
- Address
- P.O. Box 1421 Friendswood TX US 77546 77546
FDA Registration Numbers#
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JMX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780847 | NINHYDRIN REAGENT KIT | Beckman Instruments, Inc. | 1978-06-13 |
Legacy Summary#
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FDA Review#
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