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FDA 510(k)

HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2

K-Number: K780652 · 1978-07-27

ApplicantThe London Co.
Decision Date1978-07-27
Product CodeJKS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 is the device name listed in this FDA 510(k) record. The listed applicant is The London Co.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780652. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2?

HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is The London Co.. The 510(k) number is K780652.

When did HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 receive FDA 510(k) clearance?

HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780652.

Who is the listed applicant for HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2?

The FDA 510(k) record lists The London Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2?

The FDA product code for HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 is JKS.

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Other records listing The London Co. 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.

K802846TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.K801848ICA1 IONIZED CALCIUM ANALYZERK800224RADIOMETER ACID BASE LABORATORY-ABL-3K771444QUALICHECK TMK771263RADIOMHTER OSM-2 HEMOXIMETERK760229ACID BASE SYSTEM, RADIOMETER AUTOMATED

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Related Devices (Code: JKS)

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.

K951485AVOXIMETER 4000A-Vox Systems, Inc.K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific IndustriesK862253IL 482 CO-OXIMETERInstrumentation Laboratory COK853990OSM3 HEMOXIMETERRadiometer America, Inc.K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.K833211BILE SALTS MIXTUREAcumedia Manufacturers, 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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