510(k) K061889
- Device
- BIOSTAR OIA SHIGATOX
- Applicant
- INVERNESS MEDICAL-BIOSTAR INC.
- 510(k) number
- K061889
- Product code
- GMZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-12-12
- Date received
- 2006-07-03
- Regulation
- 866.3255
- Classification name
- Antigens, All Types, Escherichia Coli
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBIN C HART
- Address
- 331 S. 104th St. Louisville CO US 80516 80516
FDA Registration Numbers#
- 9611882
- 3005360469
- 3003750284
- 3009935129
- 2182595
- 8010383
- 3014684020
- 9610140
- 1524213
- 1122855
Source Documents#
Other 510(k) Records For Product Code GMZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023-04-17 |
| K121364 | SHIGA TOXIN QUIK CHEK | Techlab Inc., Corporate Research Center | 2012-10-02 |
| K121411 | SHIGA TOXIN CHEK | Techlab Inc., Corporate Research Center | 2012-10-02 |
| K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | Meridian Bioscience, Inc. | 2007-02-14 |
| K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | Meridian Bioscience, Inc. | 2003-01-03 |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Meridian Diagnostics, Inc. | 1999-08-09 |
| K980507 | PROSPECT SHIGA TOXIN MICROPLATE ASSAY | Alexon - Trend, Inc. | 1998-04-23 |
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | Shared Systems, Inc. | 1998-01-02 |
| K971663 | WELLCOLEX E.COLI O157:H7 | Murex Biotech , Ltd. | 1997-12-30 |
| K972156 | QUIX RAPID E. COLI O157 STRIP TEST | Guardian Scientific, Corp. | 1997-10-16 |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | Lmd Laboratories | 1995-09-27 |
| K944421 | E.COLI 0157 LATEX TEST | Pro-Lab Diagnostics | 1994-12-15 |
| K884513 | PF TEST | Medi-Tech, Inc. | 1989-02-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary