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FDA 510(k)

PULSE IM RED CELL TEST

K-Number: K923767 · 1992-10-16

ApplicantPulse Scientific, Inc.
Decision Date1992-10-16
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PULSE IM RED CELL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Scientific, Inc.. It received FDA 510(k) clearance on 1992-10-16 under 510(k) number K923767. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE IM RED CELL TEST?

PULSE IM RED CELL TEST is a medical device that received FDA 510(k) clearance on 1992-10-16. The listed applicant is Pulse Scientific, Inc.. The 510(k) number is K923767.

When did PULSE IM RED CELL TEST receive FDA 510(k) clearance?

PULSE IM RED CELL TEST received FDA 510(k) clearance on 1992-10-16, under 510(k) number K923767.

Who is the listed applicant for PULSE IM RED CELL TEST?

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

What is the FDA product code for PULSE IM RED CELL TEST?

The FDA product code for PULSE IM RED CELL TEST is KTN.

Related Clinical Trials

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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Other records listing Pulse Scientific, 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.

K923768PULSE CRP TESTK923771PULSE RF TEST

Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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