Medical Device Manufacturer · US , San Diego , CA

Wyntek Diagnostics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1995

Recent clearances: OSOM HCG-URINE TEST MODEL 101, OSOM CARD HCG-URINE TEST, OSOM MONO TEST 143

Total

Cleared

Denied

Wyntek Diagnostics, Inc. has 12 FDA 510(k) cleared chemistry devices. Based in San Diego, US.

Historical record: 12 cleared submissions from 1995 to 2000.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Wyntek Diagnostics, Inc. is one of 7024 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Wyntek Diagnostics, Inc.

12 devices

1-12 of 12

Cleared Jan 18, 2000

OSOM ULTRA STREP A TEST, MODEL 147

K992658 · GTY

Microbiology · 162d

Cleared Mar 09, 1999

OSOM CARD PREGNANCY TEST, MODEL 103

K990576 · LCX

Chemistry · 14d

Cleared Mar 09, 1999

OSOM CARD II HCG-URINE TEST, MODEL 102

K990578 · JHI

Chemistry · 14d

Cleared Dec 24, 1997

OSOM HCG-URINE TEST MODEL 101

K974159 · JHI

Chemistry · 71d

Cleared Nov 04, 1997

OSOM CARD HCG-URINE TEST

PERFECTA PREGNANCY TEST

K965184 · LCX

Chemistry · 42d

Cleared Feb 04, 1997

OSOM CLASSIC HCG-URINE TEST (115)

WYNTEK OSOM HCG-URINE TEST

K953383 · JHI

Chemistry · 41d

Wyntek Diagnostics, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Wyntek Diagnostics, Inc.

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