Saf Fixative

FDA 510(k) K831058 · American Micro Scan

Substantially Equivalent

510(k) numberK831058

Submission

Device name
Saf Fixative
Applicant
American Micro Scan
Mchenry, IL, US
Received
April 1, 1983
Decision date
June 8, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDW – Fixative, Acid Containing
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code LDW

510(k)DeviceApplicantDecision
K883062Ats Schaudinn's Fixative W/Acetic AcidLDW · Traditional Alpha-Tec Systems, Inc.08/04/1988SE
K842923Picric Acid 1% W/VLDW · Traditional E K Ind., Inc.09/11/1984SE
K842922Picric Acid Saturated SolutionLDW · Traditional E K Ind., Inc.09/07/1984SE

More from E K Ind., Inc.

510(k)DeviceDecision
K870029Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional 03/25/1987SE
K864662Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional 03/25/1987SE
K863776Microdilution Mic PanelsJWY · Traditional 02/02/1987SE
K864674Microdilution Identification PanelsJSE · Traditional 01/05/1987SE
K864389Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional 12/04/1986SE
K863038Gram Positive Fluorescent Identification PanelLQL · Traditional 09/30/1986SE
K862642Gram Negative Fluorescent Identification PanelLQM · Traditional 09/11/1986SE
K862332Anaerobe Rapid Chromogenic Id PanelJSP · Traditional 08/27/1986SE
K862140Microdilution PanelsJWY · Traditional 07/16/1986SE
K861584Gram Negative Combo Panel Type 3JWY · Traditional 06/17/1986SE

Questions and answers

When was Saf Fixative cleared by the FDA?

Saf Fixative (K831058) 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 K831058?

The FDA product code is LDW – Fixative, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.