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FDA 510(k)

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP

K-Number: K852125 · 1985-07-30

ApplicantKallestad Laboratories, Inc.
Decision Date1985-07-30
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K852125. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP?

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K852125.

When did PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP receive FDA 510(k) clearance?

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852125.

Who is the listed applicant for PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP?

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

What is the FDA product code for PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP?

The FDA product code for PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP is GQL.

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Other records listing Kallestad Laboratories, 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, 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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