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FDA 510(k)

AIM SYSTEM (FOR IGG)

K-Number: K811126 · 1981-05-08

ApplicantIcl Scientific
Decision Date1981-05-08
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AIM SYSTEM (FOR IGG) is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K811126. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIM SYSTEM (FOR IGG)?

AIM SYSTEM (FOR IGG) is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Icl Scientific. The 510(k) number is K811126.

When did AIM SYSTEM (FOR IGG) receive FDA 510(k) clearance?

AIM SYSTEM (FOR IGG) received FDA 510(k) clearance on 1981-05-08, under 510(k) number K811126.

Who is the listed applicant for AIM SYSTEM (FOR IGG)?

The FDA 510(k) record lists Icl Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIM SYSTEM (FOR IGG)?

The FDA product code for AIM SYSTEM (FOR IGG) is DEW.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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