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FDA 510(k)

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE

K-Number: K873756 · 1987-10-15

ApplicantDiagnostic Products Corp.
Decision Date1987-10-15
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1987-10-15 under 510(k) number K873756. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE?

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K873756.

When did LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE receive FDA 510(k) clearance?

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE received FDA 510(k) clearance on 1987-10-15, under 510(k) number K873756.

Who is the listed applicant for LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE?

The FDA product code for LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE is LCM.

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Other records listing Diagnostic Products Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: LCM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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