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FDA 510(k)

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)

K-Number: K944933 · 1995-03-10

ApplicantDiagnostic Products Corp.
Decision Date1995-03-10
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) 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 1995-03-10 under 510(k) number K944933. The device is classified under product code JMF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)?

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K944933.

When did IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) receive FDA 510(k) clearance?

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) received FDA 510(k) clearance on 1995-03-10, under 510(k) number K944933.

Who is the listed applicant for IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)?

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 (HPL) (HUMAN PLACENTAL PLACTOGEN)?

The FDA product code for IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) is JMF.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: JMF)

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.

K840588AMERLEX HUMAN PLACENTAL LACTOGENAmersham Corp.K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & ScientificK823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.K811370NATAL-TEC HPLArmkel, LLCK802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, Inc.K791854CENTRIA HPL RIAUnion Carbide Corp.

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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