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FDA 510(k)

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN

K-Number: K850999 · 1985-04-08

ApplicantTechnicon Instruments Corp.
Decision Date1985-04-08
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850999. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN?

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K850999.

When did TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN receive FDA 510(k) clearance?

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850999.

Who is the listed applicant for TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN?

The FDA product code for TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN is JJF.

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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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