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FDA 510(k)

PACKS-4 (TM) ANALYZER

K-Number: K912201 · 1991-08-16

ApplicantHelena Laboratories
Decision Date1991-08-16
Product CodeJBY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PACKS-4 (TM) ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912201. The device is classified under product code JBY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACKS-4 (TM) ANALYZER?

PACKS-4 (TM) ANALYZER is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Helena Laboratories. The 510(k) number is K912201.

When did PACKS-4 (TM) ANALYZER receive FDA 510(k) clearance?

PACKS-4 (TM) ANALYZER received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912201.

Who is the listed applicant for PACKS-4 (TM) ANALYZER?

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 PACKS-4 (TM) ANALYZER?

The FDA product code for PACKS-4 (TM) ANALYZER is JBY.

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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: JBY)

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.

K771198LUMI-AGGREGOMETERChrono-Log Corp.

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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