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FDA 510(k)

AMERI CLEAR

K-Number: K832011 · 1983-08-12

ApplicantStephens Scientific
Decision Date1983-08-12
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

AMERI CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Stephens Scientific. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832011. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERI CLEAR?

AMERI CLEAR is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Stephens Scientific. The 510(k) number is K832011.

When did AMERI CLEAR receive FDA 510(k) clearance?

AMERI CLEAR received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832011.

Who is the listed applicant for AMERI CLEAR?

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

What is the FDA product code for AMERI CLEAR?

The FDA product code for AMERI CLEAR is KEM.

Related Clinical Trials

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Other records listing Stephens Scientific 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.

K893772TISSUE EMBEDDING MEDIUMK881359DECALCIFYING SOLUTION IIK872625DECALCIFYING SOLUTION

Related Devices (Code: KEM)

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.

K881282XYLENEAnatech, Ltd.K874461HEMO-SOLChem Pharm, Inc.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena LaboratoriesK855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K853694XYLENE SUBSTITUTELerner Laboratories, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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