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FDA 510(k)

REPTILASE-R HA35

K-Number: K840210 · 1984-04-23

ApplicantWellcome Diagnostics
Decision Date1984-04-23
Product CodeJCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REPTILASE-R HA35 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K840210. The device is classified under product code JCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPTILASE-R HA35?

REPTILASE-R HA35 is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Wellcome Diagnostics. The 510(k) number is K840210.

When did REPTILASE-R HA35 receive FDA 510(k) clearance?

REPTILASE-R HA35 received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840210.

Who is the listed applicant for REPTILASE-R HA35?

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

What is the FDA product code for REPTILASE-R HA35?

The FDA product code for REPTILASE-R HA35 is JCO.

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Related Devices (Code: JCO)

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.

K955115VENOM TIEM REAGENTMedical Diagnostic Technologies, Inc.K932787BATROXOBIN REAGENTBehring Diagnostics, Inc.K896033FDP COLLECTION TUBESMedical Diagnostic Technologies, Inc.K852519DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBEE.I. Dupont DE Nemours & Co., Inc.K843207REPTILASE -PCBio/Data Corp.K780355ATROXINSigma Chemical 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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