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FDA 510(k)

CULTURESET HSV ISOLATION & ID SYS

K-Number: K842216 · 1985-01-29

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1985-01-29
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURESET HSV ISOLATION & ID SYS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-01-29 under 510(k) number K842216. 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 CULTURESET HSV ISOLATION & ID SYS?

CULTURESET HSV ISOLATION & ID SYS is a medical device that received FDA 510(k) clearance on 1985-01-29. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K842216.

When did CULTURESET HSV ISOLATION & ID SYS receive FDA 510(k) clearance?

CULTURESET HSV ISOLATION & ID SYS received FDA 510(k) clearance on 1985-01-29, under 510(k) number K842216.

Who is the listed applicant for CULTURESET HSV ISOLATION & ID SYS?

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

What is the FDA product code for CULTURESET HSV ISOLATION & ID SYS?

The FDA product code for CULTURESET HSV ISOLATION & ID SYS is GQL.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

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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