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FDA 510(k)

OSMOTIC PRESSURE AUTO & STAT OM-6010

K-Number: K842750 · 1984-08-17

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-08-17
Product CodeJJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSMOTIC PRESSURE AUTO & STAT OM-6010 is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842750. The device is classified under product code JJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMOTIC PRESSURE AUTO & STAT OM-6010?

OSMOTIC PRESSURE AUTO & STAT OM-6010 is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K842750.

When did OSMOTIC PRESSURE AUTO & STAT OM-6010 receive FDA 510(k) clearance?

OSMOTIC PRESSURE AUTO & STAT OM-6010 received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842750.

Who is the listed applicant for OSMOTIC PRESSURE AUTO & STAT OM-6010?

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

What is the FDA product code for OSMOTIC PRESSURE AUTO & STAT OM-6010?

The FDA product code for OSMOTIC PRESSURE AUTO & STAT OM-6010 is JJM.

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Other records listing Kyoto Diagnostics, 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.

K861733ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK843003GLUCOSE AUTO& STAT GA-1120K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIPK841713KYOTEST UG URINE TEST REAGENT STRIP

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Related Devices (Code: JJM)

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.

K965036THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.K873642OSMOMETER MODEL 110Advanced Instruments, Inc.K843997AO-10 AUTOMATED OSMOMETERbioMerieux, 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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