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FDA 510(k)

DADE BLOOD GAS AMPUL INJECTOR

K-Number: K852285 · 1985-07-09

ApplicantAmerican Dade
Decision Date1985-07-09
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE BLOOD GAS AMPUL INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852285. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE BLOOD GAS AMPUL INJECTOR?

DADE BLOOD GAS AMPUL INJECTOR is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is American Dade. The 510(k) number is K852285.

When did DADE BLOOD GAS AMPUL INJECTOR receive FDA 510(k) clearance?

DADE BLOOD GAS AMPUL INJECTOR received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852285.

Who is the listed applicant for DADE BLOOD GAS AMPUL INJECTOR?

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

What is the FDA product code for DADE BLOOD GAS AMPUL INJECTOR?

The FDA product code for DADE BLOOD GAS AMPUL INJECTOR is JQW.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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