Cleared Traditional

K830804 - LABILE REMOVING HEMOLYZING REAGENT

K830804 is the FDA 510(k) clearance for LABILE REMOVING HEMOLYZING REAGENT by Corning Medical & Scientific. It is a Class 2 Hematology device (product code JBD) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K830804 · Corning Medical & Scientific · Hematology device
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May 1983
Decision
51d
Days
Class 2
Risk

K830804 is an FDA 510(k) clearance for the LABILE REMOVING HEMOLYZING REAGENT. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7440 - the FDA hematology device 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K830804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date May 04, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBD System, Analysis, Electrophoretic Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7440
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 Hematology devices follow this clearance model.

Regulatory Peers - JBD System, Analysis, Electrophoretic Hemoglobin

All 18
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K830804.
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K931503 · Helena Laboratories · Aug 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
K931465 · Helena Laboratories · Jul 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K901143 · Helena Laboratories · May 1990
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · Helena Laboratories · Dec 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
K810919 · Isolab, Inc. · Apr 1981
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
K802884 · Corning Medical & Scientific · Dec 1980