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FDA 510(k)

SPECIALTY ASSAYED CONTROL-1

K-Number: K941737 · 1994-10-07

ApplicantHelena Laboratories
Decision Date1994-10-07
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECIALTY ASSAYED CONTROL-1 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K941737. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIALTY ASSAYED CONTROL-1?

SPECIALTY ASSAYED CONTROL-1 is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Helena Laboratories. The 510(k) number is K941737.

When did SPECIALTY ASSAYED CONTROL-1 receive FDA 510(k) clearance?

SPECIALTY ASSAYED CONTROL-1 received FDA 510(k) clearance on 1994-10-07, under 510(k) number K941737.

Who is the listed applicant for SPECIALTY ASSAYED CONTROL-1?

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 SPECIALTY ASSAYED CONTROL-1?

The FDA product code for SPECIALTY ASSAYED CONTROL-1 is GIZ.

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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: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade Behring, 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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