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FDA 510(k)

TRIGLYCERIDE C-37 RAPID STAT KIT

K-Number: K780825 · 1978-05-26

ApplicantPierce Chemical Co.
Decision Date1978-05-26
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE C-37 RAPID STAT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1978-05-26 under 510(k) number K780825. The device is classified under product code JGY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDE C-37 RAPID STAT KIT?

TRIGLYCERIDE C-37 RAPID STAT KIT is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is Pierce Chemical Co.. The 510(k) number is K780825.

When did TRIGLYCERIDE C-37 RAPID STAT KIT receive FDA 510(k) clearance?

TRIGLYCERIDE C-37 RAPID STAT KIT received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780825.

Who is the listed applicant for TRIGLYCERIDE C-37 RAPID STAT KIT?

The FDA 510(k) record lists Pierce Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDE C-37 RAPID STAT KIT?

The FDA product code for TRIGLYCERIDE C-37 RAPID STAT KIT is JGY.

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Other records listing Pierce Chemical Co. 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.

K895661GLYCOTEST II GLYHB ASSAY KITK831837CLINOVATIVE II DIAGNOSTIC KITK821360GLYCO-GEL TEST KITK820279GLYCO-GEL TEST KITK781897STAT KIT, MICROPROTEINK780827URIC ACID RAPID STAT KIT

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Related Devices (Code: JGY)

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.

K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K971005TRIGLYCERIDESDerma Media Lab., Inc.K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, 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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