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FDA 510(k)

TRIGLYZYME V EIKEN

K-Number: K821106 · 1982-05-05

ApplicantSyn-Kit, Inc.
Decision Date1982-05-05
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYZYME V EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1982-05-05 under 510(k) number K821106. 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 TRIGLYZYME V EIKEN?

TRIGLYZYME V EIKEN is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K821106.

When did TRIGLYZYME V EIKEN receive FDA 510(k) clearance?

TRIGLYZYME V EIKEN received FDA 510(k) clearance on 1982-05-05, under 510(k) number K821106.

Who is the listed applicant for TRIGLYZYME V EIKEN?

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

What is the FDA product code for TRIGLYZYME V EIKEN?

The FDA product code for TRIGLYZYME V EIKEN is JGY.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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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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