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FDA 510(k)

SAF FIXATIVE

K-Number: K831058 · 1983-06-08

ApplicantAmerican Micro Scan
Decision Date1983-06-08
Product CodeLDW
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SAF FIXATIVE is the device name listed in this FDA 510(k) record. The listed applicant is American Micro Scan. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831058. The device is classified under product code LDW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAF FIXATIVE?

SAF FIXATIVE is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is American Micro Scan. The 510(k) number is K831058.

When did SAF FIXATIVE receive FDA 510(k) clearance?

SAF FIXATIVE received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831058.

Who is the listed applicant for SAF FIXATIVE?

The FDA 510(k) record lists American Micro Scan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAF FIXATIVE?

The FDA product code for SAF FIXATIVE is LDW.

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Other records listing American Micro Scan as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K864662CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARSK870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEK863776MICRODILUTION MIC PANELSK864674MICRODILUTION IDENTIFICATION PANELSK864389CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TESTK863038GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

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Related Devices (Code: LDW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883062ATS SCHAUDINN'S FIXATIVE W/ACETIC ACIDAlpha-Tec Systems, Inc.K842923PICRIC ACID 1% W/VE K Ind., Inc.K842922PICRIC ACID SATURATED SOLUTIONE K Ind., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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