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FDA 510(k)

PVA FIXATIVE/FORMALIN

K-Number: K831061 · 1983-06-08

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

Device Summary

PVA FIXATIVE/FORMALIN 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 K831061. The device is classified under product code LDZ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVA FIXATIVE/FORMALIN?

PVA FIXATIVE/FORMALIN 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 K831061.

When did PVA FIXATIVE/FORMALIN receive FDA 510(k) clearance?

PVA FIXATIVE/FORMALIN received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831061.

Who is the listed applicant for PVA FIXATIVE/FORMALIN?

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 PVA FIXATIVE/FORMALIN?

The FDA product code for PVA FIXATIVE/FORMALIN is LDZ.

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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: LDZ)

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.

K883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.K881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVESurgipath Medical Industries, Inc.K881698ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.K862725SACCOMANNO SPECIMAN SOLUTIONMill-Rose LaboratoryK843428BIOFIXAccra Laboratories, Inc.K842913WRIGHT STAIN FIXATIVEE 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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