Atlas FDA

PRODIMED MICROINJECTION PIPETTES

FDA 510(k) clearance K983713 · decided 1999-06-08

Clearance details

K-number
K983713
Device name
PRODIMED MICROINJECTION PIPETTES
Applicant
Prodimed
Decision
Substantially Equivalent
Date received
1998-10-21
Decision date
1999-06-08
Days to decision
230 days
Clearance type
Traditional
Product code
MQH
Device class
2
Regulation number
884.6130
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Ringoes, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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BIOPSY PIPETTES (K133257)Research Instruments , Ltd.2014-05-16
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA (K102480)Jieying Laboratory, Inc.2011-04-19
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (K092554)Sunlight Medical, Inc.2010-04-30
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES (K072600)Sunlight Medical, Inc.2008-05-19
THE STRIPPER PGD (K041435)Mid-Atlantic Diagnostics, Inc.2004-09-29
CRYOTIP (K041562)Irvine Scientific Sales Co., Inc.2004-08-09

Recalls involving this device

No recalls on record reference this clearance.