510(k) K873132
- Device
- BUN REAGENT KIT
- Applicant
- A-KEM, INC.
- 510(k) number
- K873132
- Product code
- LFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-23
- Date received
- 1987-08-10
- Regulation
- 862.1770
- Classification name
- Conductivity Rate, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN LEE
- Address
- P.O. Box 1589 82 Industrial E. Clifton NJ US 07015 07015
FDA Registration Numbers#
- 3011989923
- 2050010
- 2050012
- 9680746
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990039 | GAMBRO DQM 200 | Gambro Healthcare | 2000-01-27 |
| K992847 | HICHEM BUN REAGENT | Elan Holdings, Inc. | 1999-10-14 |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | 1993-12-17 |
| K812945 | LIQUILYME BUN REAGENT | Amresco, Inc. | 1981-11-06 |
Legacy Summary#
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FDA Review#
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