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FDA 510(k)

SPQ PAL CONTROL LEVEL II

K-Number: K934966 · 1994-01-11

ApplicantIncstar Corp.
Decision Date1994-01-11
Product CodeDDS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ PAL CONTROL LEVEL II is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1994-01-11 under 510(k) number K934966. The device is classified under product code DDS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ PAL CONTROL LEVEL II?

SPQ PAL CONTROL LEVEL II is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Incstar Corp.. The 510(k) number is K934966.

When did SPQ PAL CONTROL LEVEL II receive FDA 510(k) clearance?

SPQ PAL CONTROL LEVEL II received FDA 510(k) clearance on 1994-01-11, under 510(k) number K934966.

Who is the listed applicant for SPQ PAL CONTROL LEVEL II?

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 PAL CONTROL LEVEL II?

The FDA product code for SPQ PAL CONTROL LEVEL II is DDS.

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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)K960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960367INCSTAR RUBELLA IGG ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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Related Devices (Code: DDS)

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.

K972812RAICHEM PREALBUMIN SPIAHemagen Diagnostics, Inc.K964781IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENTBeckman Instruments, Inc.K854811ICS PAB PREALBUMIN REAGENT TEST KITBeckman Instruments, 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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