510(k) K962609
- Device
- GRAM NEGATIVE IDENTIFICATION PLUS CARD
- Applicant
- BIOMERIEUX VITEK, INC.
- 510(k) number
- K962609
- Product code
- LRH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-30
- Date received
- 1996-07-03
- Regulation
- 866.2660
- Classification name
- Instrument For Auto Reader Of Overnight Microorganism Identification System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID K BROADWAY
- Address
- 595 Anglum Dr. Hazelwood MO US 63042 63042
FDA Registration Numbers#
- 3009241524
- 1950204
Source Documents#
Other 510(k) Records For Product Code LRH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | Dade Microscan, Inc. | 1996-05-30 |
| K926248 | READER | Alamar Biosciences Laboratory, Inc. | 1994-05-17 |
| K920225 | AUTOSCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-22 |
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