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FDA 510(k)

POLYPET

K-Number: K860617 · 1986-03-03

ApplicantInstrumed, Inc.
Decision Date1986-03-03
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POLYPET is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed, Inc.. It received FDA 510(k) clearance on 1986-03-03 under 510(k) number K860617. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYPET?

POLYPET is a medical device that received FDA 510(k) clearance on 1986-03-03. The listed applicant is Instrumed, Inc.. The 510(k) number is K860617.

When did POLYPET receive FDA 510(k) clearance?

POLYPET received FDA 510(k) clearance on 1986-03-03, under 510(k) number K860617.

Who is the listed applicant for POLYPET?

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

What is the FDA product code for POLYPET?

The FDA product code for POLYPET is JTC.

Related Clinical Trials

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Other records listing Instrumed, 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.

K952038CLEAN-CUFFK940615ACCUTESTK924273ACCUFLATEK924373ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMPK910512ACCUFLATEK890014DISPOSABLE COLOR-CUFFS

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Related Devices (Code: JTC)

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.

K924907FILTERMATE UNIVERSAL HARVESTERPackard Instrument Co., Inc.K901808MICROMATE 196 MODEL A961960Packard Instrument Co., Inc.K894645IMMULON 1,2,3,AND 4 DIVIDASTRIPS TMDynatech Laboratories, Inc.K892369MULTI-PROBE HEAD PLUSHamilton Co.K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERGenetic Systems Corp.K891765GENETIC SYSTEMS PIPETTOR/DILUTORGenetic Systems Corp.

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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