Cleared Traditional

K875135 - EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL

K875135 is an FDA 510(k) clearance for EMIT 700 CANNABINOID 100 NG CALIBRATOR ..., manufactured by Syva Co.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K875135

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.

DLJ Device Classification - Class 2, Special Controls

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 110
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