PF Test
FDA 510(k) K884513 · Medi-Tech, Inc.
510(k) numberK884513
Submission
- Device name
- PF Test
- Applicant
- Medi-Tech, Inc.
Somerset, NJ, US - Received
- October 27, 1988
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMZ – Antigens, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Specialty
- Microbiology
Other 510(k)s with product code GMZ
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|---|---|---|---|
| K222829 | Curian® Shiga ToxinGMZ · Traditional | Meridian Bioscience, Inc. | 04/17/2023SE |
| K121411 | Shiga Toxin ChekGMZ · Traditional | Techlab Inc., Corporate Research Center | 10/02/2012SE |
| K121364 | Shiga Toxin Quik ChekGMZ · Traditional | Techlab Inc., Corporate Research Center | 10/02/2012SE |
| K062546 | Immunocard Stat! Ehec, Model 751630GMZ · Traditional | Meridian Bioscience, Inc. | 02/14/2007SE |
| K061889 | Biostar Oia ShigatoxGMZ · Traditional | Inverness Medical-Biostar, Inc. | 12/12/2006SE |
| K023599 | Immunocard Stat! E. Coli O157 PlusGMZ · Traditional | Meridian Bioscience, Inc. | 01/03/2003SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | Meridian Diagnostics, Inc. | 08/09/1999SE |
| K980507 | Prospect Shiga Toxin Microplate AssayGMZ · Traditional | Alexon - Trend, Inc. | 04/23/1998SE |
| K973457 | Chromalex E. Coli 0157 Latex Test System, Prod. No. 800GMZ · Traditional | Shared Systems, Inc. | 01/02/1998SE |
| K971663 | Wellcolex E.Coli O157:H7GMZ · Traditional | Murex Biotech , Ltd. | 12/30/1997SE |
More from Murex Biotech , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | 05/15/1996SE |
| K952345 | Medi-Tech Platform Guide CatheterDQY · Traditional | 08/17/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | 12/13/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was PF Test cleared by the FDA?
PF Test (K884513) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 99 days after the submission was received.
What is the product code of K884513?
The FDA product code is GMZ – Antigens, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.