Cleared Traditional

K982062 - CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

K982062 is an FDA 510(k) clearance for CRYO-CHECK PNP PLATELET LYSATE, manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K982062 · Precision Biologicals, Inc. · Hematology device
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Jan 1999
Decision
212d
Days
Class 2
Risk

K982062 is an FDA 510(k) clearance for the CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on January 13, 1999 after a review of 212 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Biologicals, Inc. devices

FDA 510(k) Submission Details - K982062

510(k) Number K982062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date January 13, 1999
Days to Decision 212 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 113d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGW Device Classification - Class 2, Special Controls

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GGW Test, Time, Partial Thromboplastin

All 26
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