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FDA 510(k)

AVES WRIGHT STAIN

K-Number: K820437 · 1982-03-26

ApplicantHelena Laboratories
Decision Date1982-03-26
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVES WRIGHT STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-03-26 under 510(k) number K820437. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVES WRIGHT STAIN?

AVES WRIGHT STAIN is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Helena Laboratories. The 510(k) number is K820437.

When did AVES WRIGHT STAIN receive FDA 510(k) clearance?

AVES WRIGHT STAIN received FDA 510(k) clearance on 1982-03-26, under 510(k) number K820437.

Who is the listed applicant for AVES WRIGHT STAIN?

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

What is the FDA product code for AVES WRIGHT STAIN?

The FDA product code for AVES WRIGHT STAIN is IAF.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: IAF)

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.

K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma Diagnostics, Inc.K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLCK852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, 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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