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FDA 510(k)

PARA 12 PLUS

K-Number: K901875 · 1990-05-30

ApplicantStreck Laboratories, Inc.
Decision Date1990-05-30
Product CodeJCN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PARA 12 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-30 under 510(k) number K901875. The device is classified under product code JCN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA 12 PLUS?

PARA 12 PLUS is a medical device that received FDA 510(k) clearance on 1990-05-30. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K901875.

When did PARA 12 PLUS receive FDA 510(k) clearance?

PARA 12 PLUS received FDA 510(k) clearance on 1990-05-30, under 510(k) number K901875.

Who is the listed applicant for PARA 12 PLUS?

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

What is the FDA product code for PARA 12 PLUS?

The FDA product code for PARA 12 PLUS is JCN.

Other records listing Streck Laboratories, 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.

K042587RETIC-CHEX FOR CELL-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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Related Devices (Code: JCN)

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.

K993825PARA TECH PLUS RETICSStreck Laboratories, Inc.K942209LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGHBio-RadK934497CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.K911582STAK-CHEXStreck Laboratories, Inc.K902389TRI-COUNT 16Hematronix, Inc.K902391CELL-DYN 3000 CONTROLUnipath , 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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