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FDA 510(k)

BIOFIX

K-Number: K843428 · 1984-09-27

ApplicantAccra Laboratories, Inc.
Decision Date1984-09-27
Product CodeLDZ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

BIOFIX is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-27 under 510(k) number K843428. 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 BIOFIX?

BIOFIX is a medical device that received FDA 510(k) clearance on 1984-09-27. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K843428.

When did BIOFIX receive FDA 510(k) clearance?

BIOFIX received FDA 510(k) clearance on 1984-09-27, under 510(k) number K843428.

Who is the listed applicant for BIOFIX?

The FDA 510(k) record lists Accra Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIX?

The FDA product code for BIOFIX is LDZ.

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Other records listing Accra Laboratories, Inc. 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.

K851494TWO-STEP ACID FAST BACTERIA STAINK851493KINYOUN ACID FAST STAIN KITK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843426EOSIN Y 1% ALCOHOLICK843429GRAM STAIN SET W/STABILIZED IODINE

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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 LaboratoryK842913WRIGHT STAIN FIXATIVEE K Ind., Inc.K831061PVA FIXATIVE/FORMALINAmerican Micro Scan

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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