Cleared Traditional

K800770 - SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT

K800770 is the FDA 510(k) clearance for SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT by Sclavo, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800770 · Sclavo, Inc. · Chemistry device
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Apr 1980
Decision
14d
Days
Class 2
Risk

K800770 is an FDA 510(k) clearance for the SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 14 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 Sclavo, Inc. devices

Submission Details

510(k) Number K800770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 21, 1980
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K800770.
BILIRUBIN CALIBRATOR #65071
K822479 · Emd Chemicals, Inc. · Sep 1982
BILIRUBIN CALIBRATORS
K822334 · Gilford Diagnostics · Sep 1982
CHOLESTEROL STANDARDS
K802823 · Mallinckrodt Critical Care · Dec 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · Fisher Scientific Co., LLC · Feb 1980
TSH STANDARDS & DILUENT
K792290 · Amersham Corp. · Dec 1979
DUAL COMPONENT STANDARDS
K781423 · Abbott Laboratories · Aug 1978