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FDA 510(k)

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

K-Number: K020625 · 2002-05-06

ApplicantHelena Laboratories
Decision Date2002-05-06
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2002-05-06 under 510(k) number K020625. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346?

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 is a medical device that received FDA 510(k) clearance on 2002-05-06. The listed applicant is Helena Laboratories. The 510(k) number is K020625.

When did SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 receive FDA 510(k) clearance?

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 received FDA 510(k) clearance on 2002-05-06, under 510(k) number K020625.

Who is the listed applicant for SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346?

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 SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346?

The FDA product code for SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 is CIN.

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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: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.K981373ALKPHASE-B ASSAY KITMetra Biosystems, 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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