FDA 510(k)

IMMULITE PSA CONTROL MODULE, MODEL LPSCM

K-Number: K982637 · 1998-08-12

Decision Date1998-08-12

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMMULITE PSA CONTROL MODULE, MODEL LPSCM 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 1998-08-12 under 510(k) number K982637. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE PSA CONTROL MODULE, MODEL LPSCM?

IMMULITE PSA CONTROL MODULE, MODEL LPSCM is a medical device that received FDA 510(k) clearance on 1998-08-12. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K982637.

When did IMMULITE PSA CONTROL MODULE, MODEL LPSCM receive FDA 510(k) clearance?

IMMULITE PSA CONTROL MODULE, MODEL LPSCM received FDA 510(k) clearance on 1998-08-12, under 510(k) number K982637.

Who is the listed applicant for IMMULITE PSA CONTROL MODULE, MODEL LPSCM?

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 IMMULITE PSA CONTROL MODULE, MODEL LPSCM?

The FDA product code for IMMULITE PSA CONTROL MODULE, MODEL LPSCM is JJY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Products Corp. as applicant

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCIN K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGE K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: JJY)

K162530Multichem IA PlusTechno-Path Manufacturing K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories K132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.