FDA 510(k)

PARA-8

K-Number: K791228 · 1979-08-03

Decision Date1979-08-03

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PARA-8 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 1979-08-03 under 510(k) number K791228. 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-8?

PARA-8 is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K791228.

When did PARA-8 receive FDA 510(k) clearance?

PARA-8 received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791228.

Who is the listed applicant for PARA-8?

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-8?

The FDA product code for PARA-8 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.