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FDA 510(k)

SYSTEK #1 EIKEN

K-Number: K813164 · 1981-12-31

ApplicantSyn-Kit, Inc.
Decision Date1981-12-31
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYSTEK #1 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 1981-12-31 under 510(k) number K813164. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEK #1 EIKEN?

SYSTEK #1 EIKEN is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K813164.

When did SYSTEK #1 EIKEN receive FDA 510(k) clearance?

SYSTEK #1 EIKEN received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813164.

Who is the listed applicant for SYSTEK #1 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 SYSTEK #1 EIKEN?

The FDA product code for SYSTEK #1 EIKEN is JSS.

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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: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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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