510(k) K963537
- Device
- SIGMA DIAGNOSTICS BUN REAGENT
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K963537
- Product code
- LFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-24
- Date received
- 1996-09-04
- Regulation
- 862.1770
- Classification name
- Conductivity Rate, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM R GILBERT
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 3011989923
- 2050010
- 2050012
- 9680746
Source Documents#
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 |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | 1993-12-17 |
| K873132 | BUN REAGENT KIT | A-Kem, Inc. | 1987-10-23 |
| K812945 | LIQUILYME BUN REAGENT | Amresco, Inc. | 1981-11-06 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases