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FDA 510(k)

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER

K-Number: K880302 · 1988-02-19

ApplicantHemotec, Inc.
Decision Date1988-02-19
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K880302. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER?

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Hemotec, Inc.. The 510(k) number is K880302.

When did CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER receive FDA 510(k) clearance?

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER received FDA 510(k) clearance on 1988-02-19, under 510(k) number K880302.

Who is the listed applicant for CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER?

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

What is the FDA product code for CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER?

The FDA product code for CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER is GGN.

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Related Devices (Code: GGN)

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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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