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FDA 510(k)

ORTHO* SPECIMEN COLLECTION CYTOBRUSH

K-Number: K871552 · 1987-06-26

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1987-06-26
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORTHO* SPECIMEN COLLECTION CYTOBRUSH 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 1987-06-26 under 510(k) number K871552. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO* SPECIMEN COLLECTION CYTOBRUSH?

ORTHO* SPECIMEN COLLECTION CYTOBRUSH is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K871552.

When did ORTHO* SPECIMEN COLLECTION CYTOBRUSH receive FDA 510(k) clearance?

ORTHO* SPECIMEN COLLECTION CYTOBRUSH received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871552.

Who is the listed applicant for ORTHO* SPECIMEN COLLECTION CYTOBRUSH?

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 ORTHO* SPECIMEN COLLECTION CYTOBRUSH?

The FDA product code for ORTHO* SPECIMEN COLLECTION CYTOBRUSH is HHT.

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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: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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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