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FDA 510(k)

KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS

K-Number: K853328 · 1985-11-05

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1985-11-05
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KOAGULAB 16-S SEMI-AUTOMATED COAGULATION 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 1985-11-05 under 510(k) number K853328. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS?

KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K853328.

When did KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS receive FDA 510(k) clearance?

KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS received FDA 510(k) clearance on 1985-11-05, under 510(k) number K853328.

Who is the listed applicant for KOAGULAB 16-S SEMI-AUTOMATED COAGULATION 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 KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS?

The FDA product code for KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS is JPA.

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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: JPA)

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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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