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FDA 510(k)

REP(TM) SPE PLUS-30 PROCEDURES

K-Number: K896572 · 1990-01-11

ApplicantHelena Laboratories
Decision Date1990-01-11
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP(TM) SPE PLUS-30 PROCEDURES is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K896572. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP(TM) SPE PLUS-30 PROCEDURES?

REP(TM) SPE PLUS-30 PROCEDURES is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Helena Laboratories. The 510(k) number is K896572.

When did REP(TM) SPE PLUS-30 PROCEDURES receive FDA 510(k) clearance?

REP(TM) SPE PLUS-30 PROCEDURES received FDA 510(k) clearance on 1990-01-11, under 510(k) number K896572.

Who is the listed applicant for REP(TM) SPE PLUS-30 PROCEDURES?

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-30 PROCEDURES?

The FDA product code for REP(TM) SPE PLUS-30 PROCEDURES is CFP.

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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: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim 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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