Cleared Traditional

K822477 - CREATININE STANDARD #65072

K822477 is the FDA 510(k) clearance for CREATININE STANDARD #65072 by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K822477 · Emd Chemicals, Inc. · Chemistry device
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Sep 1982
Decision
31d
Days
Class 2
Risk

K822477 is an FDA 510(k) clearance for the CREATININE STANDARD #65072. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K822477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date September 17, 1982
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 K822477.
LITHIUM DILUENT
K830283 · Shaban Mfg. Co. · Feb 1983
CALIBRATOR A
K830137 · Hi Chem, Inc. · Feb 1983
CALCIUM STANDARD, ITEM #65075
K822473 · Emd Chemicals, Inc. · Sep 1982
CHOLESTEROL STANDARD #65077
K822474 · Emd Chemicals, Inc. · Sep 1982
PHOSPHOROUS STANDARD #65073
K822476 · Emd Chemicals, Inc. · Sep 1982
ACA URINARY PROTEIN CALIBRATOR
K822232 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1982