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FDA 510(k)

HELENA FETAL-TEK 200 METHOD

K-Number: K811588 · 1981-06-25

ApplicantHelena Laboratories
Decision Date1981-06-25
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HELENA FETAL-TEK 200 METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-06-25 under 510(k) number K811588. The device is classified under product code JHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA FETAL-TEK 200 METHOD?

HELENA FETAL-TEK 200 METHOD is a medical device that received FDA 510(k) clearance on 1981-06-25. The listed applicant is Helena Laboratories. The 510(k) number is K811588.

When did HELENA FETAL-TEK 200 METHOD receive FDA 510(k) clearance?

HELENA FETAL-TEK 200 METHOD received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811588.

Who is the listed applicant for HELENA FETAL-TEK 200 METHOD?

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 FETAL-TEK 200 METHOD?

The FDA product code for HELENA FETAL-TEK 200 METHOD is JHG.

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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: JHG)

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.

K061549AMNIOSTAT-FLM-PGIrvine Scientific Sales Co., Inc.K871593TDXR FETAL LUNG MATURITYAbbott LaboratoriesK834616AMNIO STAT-FLM AGGLUTINATION TESTHana Biologics, Inc.K822150AMNISTAT-FLMHana Biologics, Inc.K813216SECURE FDI TEST KITBeckman Instruments, Inc.K790798FETAL MATURITY TEST PROCEDUREHelena Laboratories

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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