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FDA 510(k)

APTT-ES

K-Number: K935169 · 1994-12-02

ApplicantHelena Laboratories
Decision Date1994-12-02
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

APTT-ES is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K935169. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTT-ES?

APTT-ES is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Helena Laboratories. The 510(k) number is K935169.

When did APTT-ES receive FDA 510(k) clearance?

APTT-ES received FDA 510(k) clearance on 1994-12-02, under 510(k) number K935169.

Who is the listed applicant for APTT-ES?

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 APTT-ES?

The FDA product code for APTT-ES is GFO.

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: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO

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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