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FDA 510(k)

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)

K-Number: K951639 · 1995-10-13

ApplicantIncstar Corp.
Decision Date1995-10-13
Product CodeDAE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K951639. The device is classified under product code DAE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)?

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Incstar Corp.. The 510(k) number is K951639.

When did COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) receive FDA 510(k) clearance?

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) received FDA 510(k) clearance on 1995-10-13, under 510(k) number K951639.

Who is the listed applicant for COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)?

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

What is the FDA product code for COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)?

The FDA product code for COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) is DAE.

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Other records listing Incstar Corp. 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: DAE)

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.

K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FOThe Binding Site Group , Ltd.K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITThe Binding Site, Ltd.K974111QUIDEL CH50 EQ EIAQuidel Corp.K954145WAKO AUTOKIT CH50Wako Chemicals USA, 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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