FDA 510(k)

PARA 12

K-Number: K823498 · 1982-12-28

Decision Date1982-12-28

Product CodeGLQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PARA 12 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 1982-12-28 under 510(k) number K823498. The device is classified under product code GLQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA 12?

PARA 12 is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K823498.

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

PARA 12 received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823498.

Who is the listed applicant for PARA 12?

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?

The FDA product code for PARA 12 is GLQ.

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: GLQ)

K111211CELL-DYN 22 PLUS CONTROLStreck K110718CELL-CHEX WITH CPPD CRYSTALSStreck K101335CELL-CHEXStreck K090137STAK-CHEX PLUS RETICSStreck K000945PARA 12 PLUS RETICSStreck Laboratories, Inc.K994388XE CHECKStreck Laboratories, Inc.

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.