510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medscience Research Group, Inc.

West Palm Beach, FL, US

MEDSCIENCE RESEARCH GROUP, INC. appears in FDA device records in West Palm Beach, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Medscience Research Group, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Medscience, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Medscience Research Group, Inc. in 1996.

Clearances by year, as a table
510(k) clearance decisions for Medscience Research Group, Inc., by decision year
YearClearances
19961
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K960641RECAP-1FMISubstantially Equivalent

Registered establishments

FDA registered establishments for Medscience Research Group, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30101317893010131789MEDSCIENCE RESEARCH GROUP, INC.1118 25th Street, West Palm Beach, FL 33407 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1843-2016AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamineDuring an FDA inspection it was found that the products are marketed without a cleared 510k.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain