FDA 510(k)

B4182-1

K-Number: K820533 · 1982-04-08

Decision Date1982-04-08

Product CodeGIE

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

B4182-1 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 1982-04-08 under 510(k) number K820533. The device is classified under product code GIE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B4182-1?

B4182-1 is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is American Scientific Products. The 510(k) number is K820533.

When did B4182-1 receive FDA 510(k) clearance?

B4182-1 received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820533.

Who is the listed applicant for B4182-1?

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 B4182-1?

The FDA product code for B4182-1 is GIE.

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 KIT K844042BLOOD DILUTION VIAL K831634GLUCOSE REAGENT B6360-11 K831625UREA NITROGEN-BUN-REAGENTS B6360-12 K831626UREA NITROGEN-BUN-REAGENTS B6370-11A K831628CREATININE REAGENTS B6370-13

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Related Devices (Code: GIE)

K820532DISPO FIBRIN PIPET TIPS B4182-2American Scientific Products

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.