510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Good Biotech Corp.

Taichung, TW

Good Biotech Corp. appears in FDA device records in Taichung, TW. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Good Biotech Corp. between 2002 and 2007. The busiest year on record is 2002, with 4. The most recent is 2007, with 1.

Clearances by year, as a table
510(k) clearance decisions for Good Biotech Corp., by decision year
YearClearances
20024
20052
20061
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K063766TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,CDDGSubstantially Equivalent
K052617FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,DBFSubstantially Equivalent
K050713DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511DCNSubstantially Equivalent
K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-HDDZSubstantially Equivalent
K022725CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013JJXSubstantially Equivalent
K021757CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SETDCNSubstantially Equivalent
K021882CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510DCNSubstantially Equivalent
K020603CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010DCNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

MDM coverage

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