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FDA 510(k)

CARBON DIOXIDE

K-Number: K872886 · 1987-08-13

ApplicantCatachem, Inc.
Decision Date1987-08-13
Product CodeKMS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1987-08-13 under 510(k) number K872886. 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?

CARBON DIOXIDE is a medical device that received FDA 510(k) clearance on 1987-08-13. The listed applicant is Catachem, Inc.. The 510(k) number is K872886.

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

CARBON DIOXIDE received FDA 510(k) clearance on 1987-08-13, under 510(k) number K872886.

Who is the listed applicant for CARBON DIOXIDE?

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

What is the FDA product code for CARBON DIOXIDE?

The FDA product code for CARBON DIOXIDE is KMS.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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.

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.K780506CARBON DIOXIDE REAGENTSGamma Enterprises, 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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