Pva Fixative/Formalin
FDA 510(k) K831061 · American Micro Scan
510(k) numberK831061
Submission
- Device name
- Pva Fixative/Formalin
- Applicant
- American Micro Scan
Mchenry, IL, US - Received
- April 1, 1983
- Decision date
- June 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883048 | Ats Para-Set Modified Pva Fixative SolutionLDZ · Traditional | Alpha-Tec Systems, Inc. | 08/17/1988SE |
| K881922 | Cytojars Prefilled with Cytology PreservativeLDZ · Traditional | Surgipath Medical Industries, Inc. | 05/25/1988SE |
| K881698 | Ats Pva Fixative SolutionLDZ · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| K862725 | Saccomanno Speciman SolutionLDZ · Traditional | Mill-Rose Laboratory | 08/01/1986SE |
| K843428 | BiofixLDZ · Traditional | Accra Laboratories, Inc. | 09/27/1984SE |
| K842913 | Wright Stain FixativeLDZ · Traditional | E K Ind., Inc. | 09/07/1984SE |
| K761138 | Fa Tissue Fixative & Wash SetLDZ · Traditional | Zeus Scientific, Inc. | 01/06/1978SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | 03/25/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
Questions and answers
When was Pva Fixative/Formalin cleared by the FDA?
Pva Fixative/Formalin (K831061) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 68 days after the submission was received.
What is the product code of K831061?
The FDA product code is LDZ – Fixative, Alcohol Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.