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FDA 510(k)

PARA-PAK SPINCON

K-Number: K980077 · 1998-04-02

ApplicantMeridian Diagnostics, Inc.
Decision Date1998-04-02
Product CodeLKS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA-PAK SPINCON is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980077. The device is classified under product code LKS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK SPINCON?

PARA-PAK SPINCON is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K980077.

When did PARA-PAK SPINCON receive FDA 510(k) clearance?

PARA-PAK SPINCON received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980077.

Who is the listed applicant for PARA-PAK SPINCON?

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

What is the FDA product code for PARA-PAK SPINCON?

The FDA product code for PARA-PAK SPINCON is LKS.

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Other records listing Meridian 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: LKS)

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.

K053257PARA-PRO FC50Alpha-Tec Systems, Inc.K021420PARACON II/FECAL CONCENTRATOR IIPara Scientific Co.K941110PARAKITHardy DiagnosticsK941129CON-KITMedical Chemical Corp.K933370STOOL TRANSPORT/PROCESSORSage Products, Inc.K935316PARASAFE(R) FIXATIVEScientific Device Laboratory, 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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