Cleared Traditional

K770606 - ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH

K770606 is an FDA 510(k) clearance for ANALYZEO, manufactured by Damon Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K770606 · Damon Corp. · Hematology device
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May 1977
Decision
36d
Days
Class 2
Risk

K770606 is an FDA 510(k) clearance for the ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on May 6, 1977 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Damon Corp. devices

FDA 510(k) Submission Details - K770606

510(k) Number K770606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1977
Decision Date May 06, 1977
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 113d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 160
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K770606.
COAG-A-MATE 2001
K790323 · General Diagnostics · Mar 1979
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
MLA ELECTRA 750 COAGULATION TIMER
K780810 · Medical Laboratory Automation Systems, Inc. · Jun 1978
TPC-LYOPHILIZED POOLED HUMAN PLASMA
K761091 · Bio/Data Corp. · Feb 1977
VERONAL BUFFER
K761171 · Bio/Data Corp. · Jan 1977
TRIS BUFFERED SALINE
K761172 · Bio/Data Corp. · Jan 1977