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FDA 510(k)

ICS PAB PREALBUMIN REAGENT TEST KIT

K-Number: K854811 · 1986-01-24

ApplicantBeckman Instruments, Inc.
Decision Date1986-01-24
Product CodeDDS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ICS PAB PREALBUMIN REAGENT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K854811. 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 ICS PAB PREALBUMIN REAGENT TEST KIT?

ICS PAB PREALBUMIN REAGENT TEST KIT is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K854811.

When did ICS PAB PREALBUMIN REAGENT TEST KIT receive FDA 510(k) clearance?

ICS PAB PREALBUMIN REAGENT TEST KIT received FDA 510(k) clearance on 1986-01-24, under 510(k) number K854811.

Who is the listed applicant for ICS PAB PREALBUMIN REAGENT TEST KIT?

The FDA 510(k) record lists Beckman Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICS PAB PREALBUMIN REAGENT TEST KIT?

The FDA product code for ICS PAB PREALBUMIN REAGENT TEST KIT is DDS.

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Other records listing Beckman Instruments, Inc. 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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.K934966SPQ PAL CONTROL LEVEL IIIncstar Corp.

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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