FDA 510(k)

PARA 4

K-Number: K842017 · 1984-06-26

Decision Date1984-06-26

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PARA 4 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 1984-06-26 under 510(k) number K842017. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA 4?

PARA 4 is a medical device that received FDA 510(k) clearance on 1984-06-26. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K842017.

When did PARA 4 receive FDA 510(k) clearance?

PARA 4 received FDA 510(k) clearance on 1984-06-26, under 510(k) number K842017.

Who is the listed applicant for PARA 4?

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 4?

The FDA product code for PARA 4 is JPK.

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-DYN K040107CYTO-CHEX BCT K040025A1C-CELLULAR K023656SICKLE-CHEX SOLUBILITY KIT K021922MODIFICATION TO PARA 5X K020469CAL-CHEX CD PLUS

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Related Devices (Code: JPK)

K160586XN-L CHECKStreck K160590XN CHECKStreck K160588XN CHECK BFStreck K160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.