Pharma-Plast Petri Dish
FDA 510(k) K843483 · Zimmar Consulting , Ltd.
510(k) numberK843483
Submission
- Device name
- Pharma-Plast Petri Dish
- Applicant
- Zimmar Consulting , Ltd.
Mchenry, IL, US - Received
- September 6, 1984
- Decision date
- September 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K860322 | Cliniset Infusion SetFPA · Traditional | 04/07/1986SE |
| K843478 | Pharma-Plast Uridrop-UridomeKNX · Traditional | 12/05/1984SE |
| K843477 | Pharma-Plast Rectal TipFCF · Traditional | 12/05/1984SE |
| K843468 | Pharma-Plast Suction Set Type YankauerGEA · Traditional | 11/23/1984SE |
| K843469 | Pharma-Plast Suction Tip, Type Orthopae-JOL · Traditional | 11/19/1984SE |
| K843467 | Pharma-Plast Nasal Oxygen CannulaCAT · Traditional | 11/19/1984SE |
| K843466 | Pharma-Plast Oxygen CatheterBZB · Traditional | 11/19/1984SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | 11/16/1984SE |
| K843475 | Pharma-Plast Single Use OvershoesFXP · Traditional | 10/31/1984SE |
| K843473 | Pharma-Plast Insulin SyringeFMF · Traditional | 10/31/1984SE |
Questions and answers
When was Pharma-Plast Petri Dish cleared by the FDA?
Pharma-Plast Petri Dish (K843483) received a 510(k) decision of Substantially Equivalent on September 21, 1984, 15 days after the submission was received.
What is the product code of K843483?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.