PROSPECT SHIGA TOXIN MICROPLATE ASSAY
FDA 510(k) clearance K980507 · decided 1998-04-23
Clearance details
- K-number
- K980507
- Device name
- PROSPECT SHIGA TOXIN MICROPLATE ASSAY
- Applicant
- Alexon - Trend, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-10
- Decision date
- 1998-04-23
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- GMZ
- Device class
- 1
- Regulation number
- 866.3255
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Ramsey, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Curian® Shiga Toxin (K222829) | Meridian Bioscience, Inc. | 2023-04-17 |
| SHIGA TOXIN CHEK (K121411) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| SHIGA TOXIN QUIK CHEK (K121364) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546) | Meridian Bioscience, Inc. | 2007-02-14 |
| BIOSTAR OIA SHIGATOX (K061889) | Inverness Medical-Biostar, Inc. | 2006-12-12 |
| IMMUNOCARD STAT! E. COLI O157 PLUS (K023599) | Meridian Bioscience, Inc. | 2003-01-03 |
| IMMUNOCARD STAT! E. COLI O157:H7 (K990263) | Meridian Diagnostics, Inc. | 1999-08-09 |
| CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (K973457) | Shared Systems, Inc. | 1998-01-02 |
| WELLCOLEX E.COLI O157:H7 (K971663) | Murex Biotech , Ltd. | 1997-12-30 |
| QUIX RAPID E. COLI O157 STRIP TEST (K972156) | Guardian Scientific, Corp. | 1997-10-16 |
| E. COLI 0157 ELISA STOOL ASSAY (K942705) | Lmd Laboratories | 1995-09-27 |
| E.COLI 0157 LATEX TEST (K944421) | Pro-Lab Diagnostics | 1994-12-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) a recall (Z-1373-04) | Remel, Inc. | 2004-08-17 |