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FDA 510(k)

HAEM-C PLUS BLOOD REFERENCE CONTROLS

K-Number: K821956 · 1982-07-30

ApplicantBaker Instructions Corp.
Decision Date1982-07-30
Product CodeJCN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HAEM-C PLUS BLOOD REFERENCE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821956. The device is classified under product code JCN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEM-C PLUS BLOOD REFERENCE CONTROLS?

HAEM-C PLUS BLOOD REFERENCE CONTROLS is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Baker Instructions Corp.. The 510(k) number is K821956.

When did HAEM-C PLUS BLOOD REFERENCE CONTROLS receive FDA 510(k) clearance?

HAEM-C PLUS BLOOD REFERENCE CONTROLS received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821956.

Who is the listed applicant for HAEM-C PLUS BLOOD REFERENCE CONTROLS?

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

What is the FDA product code for HAEM-C PLUS BLOOD REFERENCE CONTROLS?

The FDA product code for HAEM-C PLUS BLOOD REFERENCE CONTROLS is JCN.

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Other records listing Baker Instructions Corp. as applicant

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K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK833116SPIRIT CHEMISTRY SYSTEM

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Related Devices (Code: JCN)

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.

K993825PARA TECH PLUS RETICSStreck Laboratories, Inc.K942209LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGHBio-RadK934497CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.K911582STAK-CHEXStreck Laboratories, Inc.K902391CELL-DYN 3000 CONTROLUnipath , Ltd.K902389TRI-COUNT 16Hematronix, 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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