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FDA 510(k)

HELENA HEMOGLOBIN DETECT COLUMN SYS

K-Number: K820573 · 1982-04-01

ApplicantHelena Laboratories
Decision Date1982-04-01
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA HEMOGLOBIN DETECT COLUMN SYS is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820573. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA HEMOGLOBIN DETECT COLUMN SYS?

HELENA HEMOGLOBIN DETECT COLUMN SYS is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is Helena Laboratories. The 510(k) number is K820573.

When did HELENA HEMOGLOBIN DETECT COLUMN SYS receive FDA 510(k) clearance?

HELENA HEMOGLOBIN DETECT COLUMN SYS received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820573.

Who is the listed applicant for HELENA HEMOGLOBIN DETECT COLUMN SYS?

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 HELENA HEMOGLOBIN DETECT COLUMN SYS?

The FDA product code for HELENA HEMOGLOBIN DETECT COLUMN SYS is GKA.

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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: GKA)

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.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebiaK222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp.K180762CAPI 3 HEMOGLOBIN(E)SebiaK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia

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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