Cleared Traditional

CALCULATOR, ENZYME, TURNER (K770671) - FDA 510(k) Clearance

Class I Chemistry device.

K770671 · Turner Assoc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1977
Decision
80d
Days
Class 1
Risk

K770671 is an FDA 510(k) clearance for the CALCULATOR, ENZYME, TURNER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Turner Assoc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1977 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Turner Assoc. devices

Submission Details

510(k) Number K770671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1977
Decision Date June 27, 1977
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K770671.
COMPUTER INTERFACE IL 814
K781173 · Instrumentation Laboratory CO · Sep 1978
EMIT CLINICAL PROCESSOR - CP 5000
K780881 · Syva Co. · Jun 1978
DATA REDUCTION SYSTEM, DP-3000
K770877 · Beckman Instruments, Inc. · Jul 1977
GAMMACORD II CALCULATOR INTERFACE
K761063 · Miles Laboratories, Inc. · Dec 1976
ACA DATA MATE ACCESSORY
K760739 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1976