Cleared Traditional

K875135 - EMIT 700 CANNABINOID 100 NG CALIBRATOR ...

K875135 is the FDA 510(k) clearance for EMIT 700 CANNABINOID 100 NG CALIBRATOR ... by Syva Co.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K875135 · Syva Co. · Toxicology device
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Apr 1988
Decision
113d
Days
Class 2
Risk

K875135 is an FDA 510(k) clearance for the EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 5, 1988 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K875135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1987
Decision Date April 05, 1988
Days to Decision 113 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K875135.
DU PONT ACA METHOTREXATE CALIBRATOR
K884745 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · Syva Co. · Oct 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · Em Diagnostic Systems, Inc. · May 1988
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · Em Diagnostic Systems, Inc. · Oct 1987