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FDA 510(k)

CALCIUM CHLORIDE

K-Number: K841522 · 1984-04-30

ApplicantDiatech, Inc.
Decision Date1984-04-30
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALCIUM CHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K841522. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM CHLORIDE?

CALCIUM CHLORIDE is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Diatech, Inc.. The 510(k) number is K841522.

When did CALCIUM CHLORIDE receive FDA 510(k) clearance?

CALCIUM CHLORIDE received FDA 510(k) clearance on 1984-04-30, under 510(k) number K841522.

Who is the listed applicant for CALCIUM CHLORIDE?

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

What is the FDA product code for CALCIUM CHLORIDE?

The FDA product code for CALCIUM CHLORIDE is GGW.

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Other records listing Diatech, 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.

K881685FIBRINOGENTEST-OK854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841365DIA REPTIN

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Related Devices (Code: GGW)

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.

K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co.K090105LUPOTEK KCTR2 Diagnostics, Inc.K083729HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLCK060284CRYOCHECK CLOT APCRPrecision Biologic, Inc.K042762PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 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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