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FDA 510(k)

REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)

K-Number: K901463 · 1990-06-12

ApplicantHelena Laboratories
Decision Date1990-06-12
Product CodeJQJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K901463. The device is classified under product code JQJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)?

REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Helena Laboratories. The 510(k) number is K901463.

When did REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) receive FDA 510(k) clearance?

REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) received FDA 510(k) clearance on 1990-06-12, under 510(k) number K901463.

Who is the listed applicant for REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)?

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 REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)?

The FDA product code for REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) is JQJ.

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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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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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