Cleared Traditional

K800062 - PIPET CALIBRATION KIT

K800062 is the FDA 510(k) clearance for PIPET CALIBRATION KIT by Streck Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K800062 · Streck Laboratories, Inc. · Chemistry device
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Feb 1980
Decision
31d
Days
Class 2
Risk

K800062 is an FDA 510(k) clearance for the PIPET CALIBRATION KIT. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on February 11, 1980 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K800062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1980
Decision Date February 11, 1980
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K800062.
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · Miles Laboratories, Inc. · Aug 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · Syva Co. · Jun 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1980
LITHIUM STANDARD (1MM/L)
K800042 · Gilford Diagnostics · Jan 1980
URIC ACID STANDARD
K792046 · Gilford Diagnostics · Oct 1979
SPECTRO-SUR SET
K791315 · Helena Laboratories · Aug 1979