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FDA 510(k)

ROTOR

K-Number: K831571 · 1983-06-30

ApplicantAmerican Scientific Products
Decision Date1983-06-30
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831571. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTOR?

ROTOR is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is American Scientific Products. The 510(k) number is K831571.

When did ROTOR receive FDA 510(k) clearance?

ROTOR received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831571.

Who is the listed applicant for ROTOR?

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

What is the FDA product code for ROTOR?

The FDA product code for ROTOR is JJG.

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Other records listing American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

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Related Devices (Code: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.

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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