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FDA 510(k)

CARBON DIOXIDE REAGENTS

K-Number: K780506 · 1978-05-03

ApplicantGamma Enterprises, Inc.
Decision Date1978-05-03
Product CodeKMS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780506. The device is classified under product code KMS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON DIOXIDE REAGENTS?

CARBON DIOXIDE REAGENTS is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K780506.

When did CARBON DIOXIDE REAGENTS receive FDA 510(k) clearance?

CARBON DIOXIDE REAGENTS received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780506.

Who is the listed applicant for CARBON DIOXIDE REAGENTS?

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

What is the FDA product code for CARBON DIOXIDE REAGENTS?

The FDA product code for CARBON DIOXIDE REAGENTS is KMS.

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Other records listing Gamma Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASEK771832CHLORIDE

View all 23 devices →

Related Devices (Code: KMS)

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.

K872886CARBON DIOXIDECatachem, Inc.K870025AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmerican Research Products Co.K802162CO2 COLOR REAGENT & CO2 SAMPLE DILUENTPanmed, Inc.K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMDiagnostic Solutions, 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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