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FDA 510(k)

GEMSTAR II SYSTEM

K-Number: K873617 · 1987-10-19

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1987-10-19
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMSTAR II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1987-10-19 under 510(k) number K873617. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSTAR II SYSTEM?

GEMSTAR II SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-19. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K873617.

When did GEMSTAR II SYSTEM receive FDA 510(k) clearance?

GEMSTAR II SYSTEM received FDA 510(k) clearance on 1987-10-19, under 510(k) number K873617.

Who is the listed applicant for GEMSTAR II SYSTEM?

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

What is the FDA product code for GEMSTAR II SYSTEM?

The FDA product code for GEMSTAR II SYSTEM is JJE.

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Other records listing Electro-Nucleonics Laboratories, 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.

K873925VIRGO(TM) MEASLES IGG ELISAK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISAK870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

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Related Devices (Code: JJE)

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.

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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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