Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PARA-PAK

K-Number: K811722 · 1981-07-15

ApplicantMeridian Diagnostics, Inc.
Decision Date1981-07-15
Product CodeHYI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PARA-PAK 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 1981-07-15 under 510(k) number K811722. The device is classified under product code HYI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK?

PARA-PAK is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K811722.

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

PARA-PAK received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811722.

Who is the listed applicant for PARA-PAK?

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?

The FDA product code for PARA-PAK is HYI.

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

View all 92 devices →

Related Devices (Code: HYI)

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.

K871286GRAM IODINERemel Co.K842733GRAM IODINEE K Ind., Inc.K821977GRAMSTAIN SETGranite Diagnostics, Inc.K791711IMPROVED GRAM STAIN REAGENTSCarr-Scarborough Microbiologicals, Inc.K781584GRAM STAIN KITBioscientific

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.

↑