510(k) K780847
- Device
- Ninhydrin Reagent Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K780847
- Product code
- JMX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-13
- Date received
- 1978-05-23
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
|---|---|---|---|
| K863188 | HPL RIA KIT | Biotecx Laboratories, Inc. | 1986-09-25 |