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FDA 510(k)

PROTOFLUOR Z

K-Number: K871499 · 1987-08-25

ApplicantHelena Laboratories
Decision Date1987-08-25
Product CodeJKJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTOFLUOR Z is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-08-25 under 510(k) number K871499. The device is classified under product code JKJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTOFLUOR Z?

PROTOFLUOR Z is a medical device that received FDA 510(k) clearance on 1987-08-25. The listed applicant is Helena Laboratories. The 510(k) number is K871499.

When did PROTOFLUOR Z receive FDA 510(k) clearance?

PROTOFLUOR Z received FDA 510(k) clearance on 1987-08-25, under 510(k) number K871499.

Who is the listed applicant for PROTOFLUOR Z?

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 PROTOFLUOR Z?

The FDA product code for PROTOFLUOR Z is JKJ.

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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: JKJ)

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.

K893038PROTOFLUOR ZHelena LaboratoriesK780455QUANTITATIVE DETERMINATION OF PORPHYRINSWhale Scientific, 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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