IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

Acid Phosphatase (prostatic), Tartrate Inhibited

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Pap, Models L2kpa2, L2kpa6.

Pre-market Notification Details

Device IDK000257
510k NumberK000257
Device Name:IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine
CorrespondentEdward M Levine
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJFH  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-27
Decision Date2000-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414961804 K000257 000

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