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FDA 510(k)

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

K-Number: K872628 · 1987-12-21

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1987-12-21
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST 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 1987-12-21 under 510(k) number K872628. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST?

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST is a medical device that received FDA 510(k) clearance on 1987-12-21. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K872628.

When did GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST receive FDA 510(k) clearance?

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST received FDA 510(k) clearance on 1987-12-21, under 510(k) number K872628.

Who is the listed applicant for GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST?

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 GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST?

The FDA product code for GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST is LSL.

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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)

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Related Devices (Code: LSL)

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.

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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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