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FDA 510(k)

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104

K-Number: K895528 · 1989-10-25

ApplicantHelena Laboratories
Decision Date1989-10-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-10-25 under 510(k) number K895528. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104?

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 is a medical device that received FDA 510(k) clearance on 1989-10-25. The listed applicant is Helena Laboratories. The 510(k) number is K895528.

When did GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 receive FDA 510(k) clearance?

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 received FDA 510(k) clearance on 1989-10-25, under 510(k) number K895528.

Who is the listed applicant for GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104?

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 GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104?

The FDA product code for GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 is JJX.

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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: JJX)

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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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