Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "King Diagnostics, Inc."
1–24 of 41
Search insights Median review: 60d Cleared: 100% Top manufacturer: King Diagnostics, Inc. Lead specialty: Chemistry
Cleared Oct 22, 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · JMO
King Diagnostics, Inc.
Chemistry · 106d
Cleared Aug 25, 1993
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · JIS
King Diagnostics, Inc.
Chemistry · 152d
Cleared Aug 16, 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · LBR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Jun 15, 1993
KING DIAGNOSTICS CK REAGENT
K931326 · CGS
King Diagnostics, Inc.
Chemistry · 91d
Cleared Nov 02, 1992
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · CFR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Oct 13, 1992
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · CDN
King Diagnostics, Inc.
Chemistry · 116d
Cleared Oct 05, 1992
KING DIAGNOSTICS CHLORIDE REAGENT
K922921 · CHJ
King Diagnostics, Inc.
Chemistry · 110d
Cleared Sep 30, 1992
KING DIAGNOSTICS MAGNESIUM REAGENT
K923927 · JGJ
King Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 09, 1992
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128 · CHH
King Diagnostics, Inc.
Chemistry · 75d
Cleared Sep 09, 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · JPZ
King Diagnostics, Inc.
Chemistry · 76d
Cleared Aug 18, 1992
KING DIAGNOSTIC TRIGLYCERIDES REAGENT
K922964 · CDT
King Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 04, 1992
CALCIUM (AZ III) REAGENT
K922835 · CJY
King Diagnostics, Inc.
Chemistry · 53d
Cleared Jul 15, 1992
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · CIT
King Diagnostics, Inc.
Chemistry · 71d
Cleared Jun 04, 1992
KING DIAGNOSTICS ALT (GPT) REAGENT
K922109 · CKA
King Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 17, 1992
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
K920809 · JIS
King Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 27, 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · CHH
King Diagnostics, Inc.
Chemistry · 114d
Cleared Jul 18, 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · CFR
King Diagnostics, Inc.
Chemistry · 58d
Cleared Dec 28, 1988
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · GFO
King Diagnostics, Inc.
Hematology · 64d
Cleared Oct 31, 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Aug 02, 1988
CALIBRATION KIT
K882220 · JIW
King Diagnostics, Inc.
Chemistry · 68d
Cleared Jan 27, 1988
ACID PHOSPHATASE TEST
K873726 · CKE
King Diagnostics, Inc.
Chemistry · 134d
Cleared Sep 26, 1986
ALKALINE PHOSPHATASE TEST
K862498 · CJE
King Diagnostics, Inc.
Chemistry · 87d