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FDA 510(k)

SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)

K-Number: K900939 · 1990-05-16

ApplicantIncstar Corp.
Decision Date1990-05-16
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1990-05-16 under 510(k) number K900939. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)?

SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) is a medical device that received FDA 510(k) clearance on 1990-05-16. The listed applicant is Incstar Corp.. The 510(k) number is K900939.

When did SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) receive FDA 510(k) clearance?

SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) received FDA 510(k) clearance on 1990-05-16, under 510(k) number K900939.

Who is the listed applicant for SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)?

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 SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)?

The FDA product code for SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) is KQJ.

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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 ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, 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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