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FDA 510(k)

SMI MULTIPETTOR(TM)

K-Number: K863887 · 1986-11-05

ApplicantAmerican Dade
Decision Date1986-11-05
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMI MULTIPETTOR(TM) is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K863887. 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 SMI MULTIPETTOR(TM)?

SMI MULTIPETTOR(TM) is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is American Dade. The 510(k) number is K863887.

When did SMI MULTIPETTOR(TM) receive FDA 510(k) clearance?

SMI MULTIPETTOR(TM) received FDA 510(k) clearance on 1986-11-05, under 510(k) number K863887.

Who is the listed applicant for SMI MULTIPETTOR(TM)?

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 SMI MULTIPETTOR(TM)?

The FDA product code for SMI MULTIPETTOR(TM) 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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