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FDA 510(k)

OPERA SYSTEM

K-Number: K943376 · 1994-09-14

ApplicantMiles, Inc.
Decision Date1994-09-14
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miles, Inc.. It received FDA 510(k) clearance on 1994-09-14 under 510(k) number K943376. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERA SYSTEM?

OPERA SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-14. The listed applicant is Miles, Inc.. The 510(k) number is K943376.

When did OPERA SYSTEM receive FDA 510(k) clearance?

OPERA SYSTEM received FDA 510(k) clearance on 1994-09-14, under 510(k) number K943376.

Who is the listed applicant for OPERA SYSTEM?

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

What is the FDA product code for OPERA SYSTEM?

The FDA product code for OPERA SYSTEM is JJC.

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Other records listing Miles, 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.

K950292FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEMK950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK945655CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)K941156TECHNISON AXON SYSTEM

View all 11 devices →

Related Devices (Code: JJC)

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.

K945915AVL OMNI ANALYZERAvl Scientific Corp.K945584NOVA 16 ANALYZERNova Biomedical Corp.K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare CorpK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.K881056AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030American Research Products Co.

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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